EXHIBIT 9-1  

Exhibit 9-1 has been deleted.  See Exhibit 9-12 instead.

FORM FD-766 (Front)

FORM FD-766 (Back)

EXHIBIT 9-3 

EXHIBIT 9-4 

SPECIMEN CHARGES 

Act, Section, and type of Charge				Charge Code

FD&CA 402(a)(1), 801(a)(3); ADULTERATION		CONTAM CAN

The article appears to be held in a container containing a poisonous 
or deleterious substance which may render it injurious to health.

FD&CA 402(a)(1), 801(a)(3); ADULTERATION		LISTERIA

The article appears to contain Listeria, a poisonous and deleterious 
substance which may render it injurious to health.

FD&CA 402(a)(1), 801(a)(3); ADULTERATION		SALMONELLA

The article appears to contain Salmonella, a poisonous and deleterious 
substance which may render it injurious to health.

FD&CA 402(a)(1), 801(a)(3); ADULTERATION		SHIGELLA

The article appears to contain Shigella, a poisonous and deleterious 
substance which may render it injurious to health.

FD&CA 402(a)(1), 801(a)(3); ADULTERATION		BACTERIA

The article appears to contain a poisonous and deleterious substance 
which may render it injurious to health. 

FD&CA 402(a)(1), 801(a)(3); ADULTERATION		POISONOUS

The article appears to contain a poisonous or deleterious substance 
which may render it injurious to health.

FD&CA 402(a)(1), 801(a)(3); ADULTERATION		AFLATOXIN

The article appears to contain aflatoxin, a poisonous and deleterious 
substance, which may render it injurious to health.

FD&CA 402(a)(1), 801(a)(3); ADULTERATION		EXCESS SUL

The article appears to contain excessive sulfites, a poisonous and 
deleterious substance which may render it injurious to health.

FD&CA 402(a)(2)(A), 801(a)(3); ADULTERATION		UNSAFE SUB

The article appears to bear or contain a substance which is unsafe 
within the meaning of Section 406.

FD&CA 402(a)(2)(A), 801(a)(3); ADULTERATION		FLUOROCARB

The article appears to contain chloroflurocarbons in violation of 21 
CFR 2.125.

FD&CA 402(a)(2)(B), 801(a)(3); ADULTERATION		PESTICIDE

The article appears to be a raw agricultural commodity that bears 
or contains a pesticide chemical which is unsafe within the meaning
of Section 408(a).

FD&CA 402(a)(2)(C), 801(a)(3); ADULTERATION		GINSENG

The article appears to bear or contain "Ginseng", a food additive
which is unsafe within the meaning of Section 409. (Note: Detention 
authority for this charge was cancelled with passage of the Dietary 
Supplement Act.)

FD&CA 402(a)(2)(C), 801(a)(3); ADULTERATION		UNSAFE ADD
The article appears to bear or contain a food additive which is unsafe 
within the meaning of Section 409. 

FD&CA 402(a)(3), 801(a)(3); ADULTERATION		LEAK/SWELL

The article appears to be held in swollen containers or contains 
micro leaks.

FD&CA 402(a)(3), 801(a)(3); ADULTERATION		FILTHY

The article appears to consist in whole or in part of a filthy, putrid, 
or decomposed substance or be otherwise unfit for food.

FD&CA 402(a)(3), 801(a)(3); ADULTERATION		OFF ODOR

The article appears to consist in whole or in part of a filthy, putrid, or 
decomposed substance or be otherwise unfit for food. Contains an off odor.

FD&CA 402(a)(3), 801(a)(3); ADULTERATION		FOREIGN OB

The article appears to consist in whole or in part of a filthy, putrid, 
or decomposed substance, or is otherwise unfit for food in that it 
appears to contain foreign objects.

FD&CA 402(a)(4), 801(a)(3); ADULTERATION		NO PROCESS

It appears that the manufacturer has not filed information on its 
scheduled process as required by 21 CFR 108.25(c)(2) or 108.35(c)(2).

FD&CA 402(a)(4), 801(a)(3); ADULTERATION		NEEDS FCE

It appears the manufacturer is not registered as a low acid canned 
food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1)
or 108.35(c)(1).

FD&CA 402(a)(4), 801(a)(3); ADULTERATION		SOAKED/WET

The article appears to have been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated 
with filth or whereby it may have been rendered injurious to health in 
that it appears to have been held in water.

FD&CA 402(a)(4), 801(a)(3); ADULTERATION		INSANITARY

The article appears to have been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated 
with filth or whereby it may have been rendered injurious to health.

FD&CA 402(a)(4), 801(a)(3); ADULTERATION		UNDER PRC

The article appears to have inadequate processing in having been 
prepared, packed, or held under insanitary conditions whereby it 
may have been rendered injurious to health.

FD&CA 402(a)(4), 801(a)(3); ADULTERATION		NEEDS ACID

The food appears to have been prepared, packed, or held under 
insanitary conditions or it may have been rendered injurious to health 
due to inadequate acidification.

FD&CA 402(a)(5), 801(a)(3); ADULTERATION		***

The food appears to be, in whole or in part, the product of a diseased 
animal or of an animal which has died otherwise than by slaughter.

FD&CA 402(a)(5), 801(a)(3); ADULTERATION		DISEASED

The food appears to be, in whole or in part, the product of a diseased 
animal or of an animal which has died otherwise than by slaughter.

FD&CA 402(a)(6), 801(a)(3); ADULTERATION		CONTAINER

The container appears to be composed, in whole or in part, of a 
poisonous or deleterious substance which may render the contents 
injurious to health.

FD&CA 402(b)(1), 801(a)(3); ADULTERATION		OMITTED

It appears that a valuable constituent of the article has been in whole 
or in part omitted or abstracted from the article.

FD&CA 402(b)(2), 801(a)(3); ADULTERATION		SUBSTITUTE

It appears that a substance has been substituted wholly or in part for 
one or more of the article's ingredients.

FD&CA 402(b)(3), 801(a)(3); ADULTERATION		CONCEALED

It appears to be food which has damage or inferiority concealed in 
any manner.

FD&CA 402(b)(4), 801(a)(3); ADULTERATION		ADDED BULK

The food appears to have a substance added to, mixed or packed 
with it so as to increase its bulk or weight, or reduce its quality or 
strength, or make it appear better or of greater value than it is.

FD&CA 402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDING YELLOW #5

The food appears to bear or contain the color additive FD&C Yellow 

FD&CA 402(c), 801(a)(3); ADULTERATION			UNSAFE COL

The article appears to be, or to bear, or to contain a color additive 
which is unsafe within the meaning of Section 721(a).

FD&CA 402(d)(1), 801(a)(3); ADULTERATION		IMBED OBJT

The article appears to be a confectionery that has partially or 
completely imbedded therein any non-nutritive object.

FD&CA 402(d)(2), 801(a)(3); ADULTERATION		ALCOHOL

The article appears to be a confectionery that bears or contains 
alcohol in excess of 1/2 of 1% by volume derived solely from the 
use of flavoring extracts.

FD&CA 402(d)(3), 801(a)(3); ADULTERATION		NONNUT SUB

The article appears to be confectionery and it bears or contains a 
non-nutritive substance.

FD&CA 402(e), 801(a)(3); ADULTERATION			BUTTER

The article appears to be oleo/margarine or butter with raw materials 
consisting, in whole or in part, of a filthy, putrid, or decomposed 
substance or the article is otherwise be unfit for food.

FD&CA 403(a)(1), 801(a)(3); MISBRANDING			FALSE

The labeling of the article appears to be false and misleading.

FD&CA 403(a)(2), 801(a)(3); MISBRANDING			VITAMN LBL

The food appears to be subject to section 411 and its advertising
is false or misleading in a material respect or its labeling is in 
violation of section 411(b)(2).

FD&CA 403(b), 801(a)(3); MISBRANDING			WRONG IDEN

The article appears to be offered for sale under the name of 
another food.

FD&CA 403(c), 801(a)(3); MISBRANDING			IMITATION

The article appears to be an imitation of another food and the label 
does not bear in type of uniform size and prominence, the word 
"imitation" and immediately thereafter, the name of the food imitated.

FD&CA 403(e)(1), 801(a)(3); MISBRANDING			LACKS FIRM

The food is in package form and appears to not bear a label 
containing the name and place of business of the manufacturer, 
packer, or distributor.

FD&CA 403(e)(2), 801(a)(3); MISBRANDING			LACKS N/C

The food is in package form and appears to not have a label 
containing an accurate statement of the quantity of the contents 
in terms of weight, measure, or numerical count and no variations
or exemptions have been prescribed by regulations.

FD&CA 403(f), 801(a)(3); MISBRANDING			INCONSPICU

Information required by the Act to be on the label or labeling does 
not appear to be conspicuous enough as to render it likely to be read 
and understood by an ordinary individual under customary conditions
of purchase and use.

FD&CA 403(f), 801(a)(3); MISBRANDING			NO ENGLISH

Required label or labeling appears to not be in English per 21 CFR 
101.15(c).

FD&CA 403(g)(1), 801(a)(3); MISBRANDING			STD IDENT

The food appears to be represented as a food for which a definition
and standard of identity have been prescribed by regulations as 
provided by section 401 and the food does not appear to conform 
to such definition and standard.

FD&CA 403(g)(2), 801(a)(3); MISBRANDING			OPTION ING

It appears to be a food for which a definition and standard of identity 
have been prescribed by regulations under section 401 and appears to 
not be labeled with the common names of the optional ingredients 
specified therein.

FD&CA 403(g)(2), 801(a)(3); MISBRANDING			STD NAME

It appears to be a food for which a definition and standard of identity 
have been prescribed by regulations under section 401 and appears to 
not be labelled with the name specified in the definition and standard.

FD&CA 403(h)(1), 801(a)(3); MISBRANDING			STD QUALIT

The article appears to be represented as a food for which a standard 
of quality has been prescribed by regulation as provided by Sec. 401 
and it appears its quality falls below such standard and its label does 
not so indicate.

FD&CA 403(h)(2), 801(a)(3); MISBRANDING			STD FILL

The article appears to be represented as a food for which a standard 
of fill of container has been prescribed by regulations as provided by 
section 401 and it appears it falls below the standard of fill and its 
label does not so indicate.

FD&CA 403(i)(1), 801(a)(3); MISBRANDING			USUAL NAME

It appears that the label does not bear the common or usual name
of the food.

FD&CA 403(i)(2), 801(a)(3); MISBRANDING			JUICE 

It appears the food is a beverage containing vegetable or fruit juice 
and does not bear a statement on the label in appropriate prominence 
on the information panel of the total percentage of such fruit or vegetable 
juice contained therein.

FD&CA 403(i)(2), 801(a)(3); MISBRANDING			LIST INGRE

It appears the food is fabricated from two or more ingredients and 
the label does not list the common or usual name of each ingredient.

FD&CA 403(j), 801(a)(3); MISBRANDING			DIETARY

The article purports to be or is represented for special dietary uses 
and its label does not appear to bear the nutritional information 
required by regulation.

FD&CA 403(k), 801(a)(3); MISBRANDING			PRESRV LBL

The article appears to contain a chemical preservative and it fails 
to bear labeling stating that fact including its function.

FD&CA 403(k), 801(a)(3); MISBRANDING			COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear 
labeling stating that fact.

FD&CA 403(k), 801(a)(3); MISBRANDING			FLAVR LBLG

The article appears to contain an artificial flavoring and it fails to bear 
labeling stating that fact.

FD&CA 403(o); 801(a)(3) Misbranded			SACCHARIN

The article contains saccharin, a non-nutritive sweetener, and its label 
or labeling fails to bear the required warning statement.


FD&CA 403(q); 801(a)(3); Misbranding			NUTRIT LBL

The article appears to be misbranded in that the label or labeling fails 
to bear the required nutrition information.

FD&CA 501(a)(1), 801(a)(3); ADULTERATION		FILTHY

The article appears to consist, in whole or in part, of any filthy, putrid,or 
decomposed substance.

FD&CA 501(a)(2)(A), 801(a)(3); ADULTERATION		INSANITARY

The article appears to have been prepared, packed, or held under 
insanitary conditions whereby it may have been contaminated with 
filth or whereby it may have been rendered injurious to health.

FD&CA 501(a)(2)(A), 801(a)(3); ADULTERATION		STERILITY

The article appears to have been prepared, packed, or held under 
insanitary conditions whereby it may have been contaminated with 
filth or may have been rendered injurious to health in that it is not sterile.

FD&CA 501(a)(2)(B), 801(a)(3); ADULTERATION		DRUG GMPS

It appears that the methods used in or the facilities or controls used 
for manufacture, processing, packing, or holding do not conform to or 
are not operated or administered in conformity with current good 
manufacturing practices.

FD&CA 501(a)(2)(B), 801(a)(3); ADULTERATION		TAMPERING

It appears that the packing does not conform with current good 
manufacturing practices under 21 CFR 211.132 for tamper-resistant 
packaging.

FD&CA 501(a)(3), 801(a)(3); ADULTERATION		CONTAINER

The container appears to be composed, in whole or in part, of a 
poisonous or deleterious substance which may render the contents 
injurious to health.

FD&CA 501(a)(4)(A), 801(a)(3); ADULTERATION		COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a 
color additive which is unsafe within the meaning of Section 721(a).

FD&CA 501(a)(4)(B), 801(a)(3); ADULTERATION		UNSAFE COL

The article appears to be a color additive for the purposes of coloring 
only in or on drugs or devices, and is unsafe within the meaning of 
Section 721(a).

FD&CA 501(a)(5), 801(a)(3); ADULTERATION		FLUOROCARB

The article appears to be a new animal drug containing chloroflurocarbons in 
violation of 21 CFR 2.125.

FD&CA 501(a)(5), 801(a)(3); ADULTERATION		NEW VET DR

The article appears to be a new animal drug which is unsafe within 
the meaning of Section 512.

FD&CA 501(a)(6), 801(a)(3); ADULTERATION		FEED & NAD

The article appears to be an animal feed bearing or containing a new 
animal drug and such animal feed is unsafe within the meaning of 
Section 512.

FD&CA 501(b), 801(a)(3); ADULTERATION			DR QUALITY

The article appears to be represented as a drug the name of which 
is recognized in an official compendium and its strength appears to 
differ from or its quality or purity appear to fall below the standards 
set forth in such compendium.

FD&CA 501(c), 801(a)(3); ADULTERATION			NOT IMPACT

The article appears to not have impact-resistant lenses in accordance 
with 21 CFR 801.410.

FD&CA 501(c), 801(a)(3); ADULTERATION			DR QUALITY

The drug appears to be represented as not being recognized in an
official compendium and appears its strength differs from or its quality 
or purity falls below, that which it purports or is represented to possess.

FD&CA 501(c); 801(a)(3) ADULTERATION			STAINSTEEL

The article appears to be a device whose quality falls below that 
which it purports or is represented to possess in that the instrument 
is represented as stainless steel but does not meet requirements for 
such steel for surgical instruments.

FD&CA 501(c); 801(a)(3) ADULTERATION			DV QUALITY

The article appears to be a device whose quality falls below that 
which it purports or is represented to possess.

FD&CA 501(c); 801(a)(3) ADULTERATION			HOLES

The quality of the article falls below that which it purports or is 
represented to possess, in that the devices contain defects/holes.

FD&CA 501(d)(1), 801(a)(3); ADULTERATION		REDUCED

It appears to be a drug that a substance has been mixed or packed 
with so as to reduce its strength.


FD&CA 501(d)(2), 801(a)(3); ADULTERATION		SUBSTITUTE

It appears to be a drug that a substance has been substituted 
wholly or in part.

FD&CA 501(e), 801(a)(3); ADULTERATION			FAILS STD

The article appears to be a device which is subject to a performance 
standard established under Section 514 and does not appear to be, in 
all respects, in conformity with such standard.

FD&CA 501(f)(1)(B), 801(a)(3); ADULTERATION		NO PMA

The article appears to be a class III device without an approved 
application for premarket approval pursuant to section 515(a).

FD&CA 501(g), 801(a)(3); ADULTERATION			BANNED

The article appears to be a banned device.

FD&CA 501(h), 801(a)(3); ADULTERATION			DEVICE GMP

The methods, facilities, or controls used for the article's manufacture, 
packing, storage. or installation do not conform with applicable 
requirements under section 520(f)(1) or a condition prescribed by 
an order under section 520(f)(2).

FD&CA 502(a) & (f)(1), 801(a)(3); MISBRANDING		PERSONALRX

The article appears to be a drug which requires a prescription from 
your doctor.

FD&CA 502(a) & (f)(1), 801(a)(3); MISBRANDING		RX LEGEND

The article appears to be a prescription drug without a prescription
drug legend as required by Section 503(b)(4).

FD&CA 502(a) & (f)(1), 801(a)(3); MISBRANDING		VET LEGEND

The article appears to be a veterinary drug without the caution 
statement as required by Section 503 (f)(4).

FD&CA 502(a) and/or 502(f)(1); MISBRANDING		NONSTEEL

Labeling appears false or misleading or fails to bear adequate 
directions for use, because the article appears to be misrepresented 
as a disposable single use instrument when it is intended for use as 
a stainless steel multi-use instrument.

FD&CA 502(a), 801(a)(3); MISBRANDING			FALSE

The labeling for this article appears to be false or misleading.

FD&CA 502(a), 801(a)(3); MISBRANDING			LENS CERT

The lenses are declared by accompanying certificate to meet the 
requirements for impact-resistant lenses in 21 CFR 801.410 but do 
not appear to be impact-resistant.

FD&CA 502(a),(f)(1), 801(a)(3); MISBRANDING		RX DEVICE

The article appears to be a prescription device without a prescription 
device legend as required by 21 CFR 801.109.

FD&CA 502(a); 801(a)(3); MISBRANDING			LBL STEEL

The labeling for this article appears to be false or misleading: labeling 
suggests it is composed of stainless steel, but it doesn't meet standard 
requirements for the appropriate type of stainless steel.

FD&CA 502(b)(1), 801(a)(3); MISBRANDING			LACKS FIRM

The article is in package form and appears to not bear a label 
containing the name and place of business of the manufacturer, 
packer, or distributor.

FD&CA 502(b)(2), 801(a)(3); MISBRANDING			LACKS N/C

The article is in package form and appears to not have a label 
containing an accurate statement of the quantity of the contents in 
terms of weight, measure, or numerical count and no variations or 
exemptions have been prescribed by regulations.

FD&CA 502(c), 801(a)(3); MISBRANDING			INCONSPICU

Information required by the Act to be on the label or labeling does not 
appear to be conspicuous enough as to render it likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use.

FD&CA 502(c); 801(a)(3); MISBRANDING			NO ENGLISH

Required label or labeling appears to not be in English in violation of 
21 CFR 201.15(c)(1).

FD&CA 502(e)(1); 801(a)(3); MISBRANDING			DRUG NAME

The article appears to be a drug and fails to bear the proprietary or 
established name and/or name and quantity of each active ingredient.

FD&CA 502(e)(2); 801(a)(3); MISBRANDING			DV NAME

The article appears to be a device and its labeling fails to bear the 
proprietary or established name.

FD&CA 502(f)(1), 801(a)(3); MISBRANDING			DIRECTIONS

The article appears to lack adequate directions for use.

FD&CA 502(f)(1),801(a)(3);MISBRANDING&PHS BIOL. ACT 351	NO LICENSE

The article appears to be a biological product not manufactured at an 
establishment holding an un-suspended and unrevoked license issued 
under the Public Health Service Act, Biological Products section 351.

FD&CA 502(f)(2), 801(a)(3); MISBRANDING			WARNINGS

It appears to lack adequate warnings against use in pathological 
conditions or by children where it may be dangerous to health or
against unsafe dosage, methods, administering duration, application, 
or manner and form to protect users.

FD&CA 502(j), 801(a)(3); MISBRANDING			DANGEROUS

The article appears to be dangerous to health when used in the dosage 
or manner, or with the frequency or duration, prescribed, recommended, 
or suggested in the labeling thereof.

FD&CA 502(k), 801(a)(3); MISBRANDING			INSULIN

The drug appears to purport, or represented as, being composed
wholly or partly of insulin and it does not appear to be from a batch 
with respect to which a certificate or release has been issued pursuant 
to section 506.

FD&CA 502(l), 801(a)(3); MISBRANDING			ANTIBIOTIC

The drug appears to purport, or represented as, being composed 
wholly or partly of an antibiotic and it does not appear to be from a 
batch with respect to which a certificate or release has been issued 
pursuant to section 507.

FD&CA 502(m), 801(a)(3); MISBRANDING			DRUG COLOR

The article appears to be a color additive the intended use of which is 
for the purpose of coloring only, and its packaging and labeling do not 
conform to regulations issued under section 721.

FD&CA 502(o), 801(a)(3); MISBRANDING			REGISTERED

It appears the device is subject to listing under 510(j) and the initial 
distributor has not registered as required by 21 CFR 807.20 (a)(4).


FD&CA 502(o), 801(a)(3); MISBRANDING			NOT LISTED

It appears the drug or device is not included in a list required by 
Section 510(j) or a notice or other information respecting it was not 
provided as required by section 510(j) or 510(k).

FD&CA 502(p), 801(a)(3); MISBRANDING			POISON PKG

The article appears to be a drug and its packaging and labeling is in 
violation of an applicable regulation issued pursuant to section 3 or 4 
of the Poison Prevention Packaging Act of 1970.

FD&CA 502(s), 801(a)(3); MISBRANDING			STD LABEL

The article appears to not bear labeling prescribed by the performance 
standard established under section 514.


FD&CA 502(t), 801(a)(3); MISBRANDING			RECORDS

The article appears to be a device and the requirements under 518 or 
to furnish any material or information required by or under section 519 
respecting a device were not met.

FD&CA 505(a), 801(a)(3); UNAPPROVED NEW DRUG		UNAPPROVED

The article appears to be a new drug without an approved new drug 
application.

FD&CA 536(a),(b); NON STANDARD				NON STD

It appears that the article fails to comply with applicable standards 
prescribed under section 534.

FD&CA 536(a),(b); NOT CERTIFIED				NO TAG

It appears that the article does not have affixed to it a certification in the 
form of a label or tag in conformity with section 534(h).

FD&CA 536(a); FAILURE TO FILE INITIAL REPORT		NO REGISTR

The article appears to be an electronic product that does not comply 
with an applicable standard as prescribed by Section 534 because no 
reporting has been provided as required by Section 537(b).

FD&CA 601(a), 801(a)(3); ADULTERATION			FLUOROCARB

The article appears to contain chloroflurocarbons in violation of 21 
CFR Part 2.125.

FD&CA 601(a), 801(a)(3); ADULTERATION			POISONOUS

The cosmetic appears to bear or contain a poisonous or deleterious 
substance which may render it injurious to users under the conditions 
prescribed in the labeling.

FD&CA 601(b), 801(a)(3); ADULTERATION			FILTH

The cosmetic appears to consist in whole or in part of any filthy, 
putrid, or decomposed substance.

FD&CA 601(c), 801(a)(3); ADULTERATION			HELD INSAN

The cosmetic appears to have been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated with 
filth or whereby it may have been rendered injurious to health.

FD&CA 601(d), 801(a)(3); ADULTERATION			CONTAINER

The container appears to be composed, in whole or in part, of a
poisonous or deleterious substance which may render the contents 
injurious to health.

FD&CA 601(e), 801(a)(3); ADULTERATION			COSM COLOR

The cosmetic appears to not be a hair dye, and is, bears, or contains 
a color additive which is unsafe within the meaning of section 721(a).

FD&CA 602(a)and/or(b),and/or(c),801(a)3); MISBRANDING	CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling 
requirements of Section 601(a), and/or (b), and/or (c), and as identified by 21 
CFR Part 701.

FD&CA 602(e), 801(a)(3); MISBRANDING			COLOR LBLG

The color additive appears to not have its packaging and labeling in 
conformity with such requirements as issued under section 721.

FD&CA 801(a)(1); NON CONFORMING MANUFACTURING PRACTICES	IMP GMP

The methods used in, or the facilities or controls used for, the 
manufacture, packing, storage, or installation do not conform to the 
requirements under section 520(f).

FD&CA 801(a)(2); FORBIDDEN OR RESTRICTED IN SALE	FORBIDDEN

The article appears to be forbidden or restricted in sale in the country 
in which it was produced or from which it was exported.

FD&CA 801(a)(3); 403(r)(1)(A)/(B); MISBRANDING		HEALTH C

The article appears to be misbranded in that the label or labeling bears 
an unauthorized nutrient content/health claim.

FD&CA 801(a)(3); 502(o); MISBRANDING			NO 510(K)

It appears that a notice or other information respecting the device was 
not provided to FDA, as required by Section 510(k), and the device 
was not found to be substantially equivalent to a predicate device.

FD&CA 801(d)(1),(2); IMPORTATION RESTRICTED		DRUG SAMPL

The article appears to be a prescription drug manufactured in the U.S.
and offered for import by other than the manufacturer and re-importation 
does not appear to have been authorized by the Secretary for use in a 
medical emergency.

FIMA 1, 2; PROHIBITION WITHOUT PERMIT			NO PERMIT

The article is milk or cream not subject to a valid permit.

FPLA 5(c)(3)(A); 801(a)(3); MISBRANDING			COSMETLBLG

It appears the label does not bear the common or usual name of the 
cosmetic.

FPLA 5(c)(3)(B); 801(a)(3); MISBRANDING			COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and 
the label does not list the common or usual name of each ingredient.

FPLA Section 4(a); 801(a)(3); MISBRANDING		LABELING

The article appears in violation of FPLA because of its placement, 
form, and/or contents statement.

PHSQI 361						TISSUE

This tissue is in violation of 21 CFR Part 1270. The tissue must not be
distributed and must be held intact pending recall and/or destruction,
or release.

TIA 1 (21 U.S.C. 41); PROHIBITED TEA			REJECT TEA

The article is inferior in purity, quality, and fitness for consumption to the 
standards provided in section 43. (On April 9, 1996, HR 2969 
(Public Law 104-128) was signed by the President. This law repels
the Tea Importation Act of 1897. Importers of Tea are no longer
required to submit samples of Tea to the Tea Examiner, or complete 
and submit a Tea Chop List (FDA form 1824) for each importation. 
However, tea is still regulated under provisions of the FD&CA and, as
such, requires notification of each entry to FDA.)
 

EXHIBIT 9-6 

Each package of such products imported for sale, barter, or exchange shall be labeled or plainly marked with the name, address, and license number of the manufacturer, and the date beyond which the contents cannot be expected to yield their specific results. From each lot of product the district director shall select at random at least two final containers. The random sample together with a copy of the associated documents which describe and identify the shipment shall be forwarded to the Director, Center for Biologics Evaluation and Research (CBER), 8800 Rockville Pike, Bethesda, MD 20892-001. For shipments of 20 or less final containers, samples need not be forwarded, provided a copy of an official release from the Center for Biologics Evaluation and Research accompanies each shipment.  

The random sample shall be forwarded to the Director, CBER at one of the product specific locations listed below together with a copy of the associated documents which describe and identify the shipment. 

Samples of whole blood and blood components pre-license products should be shipped by courier service and addressed to: 

Samples of all other biological products (including those for release action, in support of product release license or an amendment there to or complaint sample) shall be addressed as follows: 

[T.D. 69-201, 34 FR 14328, Sept. 12 1969 as amended by T.D. 82-145, 47 FR 35476, Aug. 16, 1982] 

21 CFR 601.22

'601.22 Products in short supply; initial manufacturing at other than licensed

Licenses issued to a manufacturer for an establishment shall authorize persons other than such manufacturer to conduct at places other than such establishment the initial, and partial manufacturing of a product for shipment solely to such manufacturer only to the extent that the names of such persons and places are registered with the Commissioner of Food and Drugs and he finds, upon application of such manufacturer, that (a) the product is in short supply due either to the peculiar growth requirements of the organism involved or to the scarcity of the animal required for manufacturing purposes, and (b) such manufacturer has established with respect to such persons and places such procedures, inspections, tests, or other arrangements as will assure full compliance with the applicable regulations of this subchapter related to continued safety , purity, and potency. Such persons and places shall be subject to all regulations of this subchapter except ''601.1 to 601.6, 601.9,601.10, 601.20, 601.21, 601.30 to 601.33, and ''610.60 to 610.65 of this chapter. Failure of such manufacturer to maintain such procedures, inspections, tests, or other arrangements, or failure of any person conducting such partial manufacturing to comply with applicable regulations shall constitute a ground for suspension or revocation of the authority conferred pursuant to this section on the same basis as provided in ''601.6 to 601.8 with respect to the suspension and the revocation of licenses.