FDA cites Pure Encapsulations for serious issues

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[Department of Health and Human Services logo]Department of Health and Human

Services

Public Health Service

Food and Drug Administration

New England District

One Montvale Avenue

Stoneham, Massachusetts 02180

FAX:

WARNING LETTER

CMS # 222054

VIA UPS

December 23, 2011

Mr. W. Bliffert

President

Pure Encapsulations, Inc.

490 Boston Post Road

Sudbury, MA 01776

Dear Mr. Bliffert:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your

dietary supplement manufacturing, packaging, labeling, and holding facility,

Pure Encapsulations, Inc., located at 490 Boston Post Road, Sudbury, MA, on

August 4-24, 2011. During the inspection, our investigators found serious

violations of the Current Good Manufacturing Practice (CGMP) regulations for

dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21

CFR Part 111). These violations cause your PhytoBalance dietary supplement

products to be adulterated within the meaning of section 402(g)(1) of the

Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that

the dietary supplements have been prepared, packed, or held under conditions

that do not meet CGMP regulations for dietary supplements.

In addition, our review of your product labeling revealed that your PhytoBalance

dietary supplements, as described further below, are in violation of the Act and

regulations implementing the food labeling requirements of the Act, which are

found in 21 CFR 101.

You can find the Act and FDA regulations through links on FDA's home page at

http://www.fda.gov<http://www.mynewsletterbuilder.com/tools/refer.php?s=55403198\

17 & u=25773525 & v=3 & key=5c88 & skey=1cc2169daf & url=http%3A%2F%2Fwww.fda.gov%2F>.

Dietary Supplement CGMP Violations

The inspection revealed the following violations:

1). You failed to reject a component that did not meet your identity

specifications established under 21 CFR 111.70((1), as required by 21 CFR

111.77(. Specifically, your firm used the dietary ingredients ((4) and((4)

to manufacture the finished product PhytoBalance (Lot No. ((4)). However,

these dietary ingredient components failed to meet identity specifications prior

to their use in the manufacture of PhytoBalance (Lot No.((4)).

Furthermore, you failed to document any material review and disposition decision

and follow-up, as required by 21 CFR 111.140((3). Specifically, your

" Nonconforming Material Report " forms for ((4) and ((4) do not include final

material disposition decisions and signatures of the individual(s) who conducted

the material review and made the disposition decisions, as required by 21 CFR

111.140((3)(vii).

We received your reply to the FDA-483 dated September 12, 2011. You stated that

you have sent the three most recent lots of ((4) for TLC identity testing.

Your response is inadequate because you did not indicate whether these lots

include the same lot that failed the identity specification during our

inspection, and you have not provided the results of this testing for

verification. You also stated that you no longer use ((4) in the manufacture

of PhytoBalance or any other product at your firm. While this may prevent future

problems with the use of ((4), it does not address your use of ((4) that

failed to meet your identity specifications in your existing product,

PhytoBalance (Lot No. ((4)).

2. You failed to ensure that the tests and examinations that you use to

determine whether the specifications are met are appropriate, scientifically

valid methods, as required by 21 CFR 111.75(h)(1). Specifically, the following

components were used as analytical standards in your FT-NIR library by

authentication using organoleptic tests and review of certificates of analyses

(CoA): ((4) The identity testing of components used to manufacture

PhytoBalance (Lot No. ((4)) was based on organoleptic testing of the above

ingredients and the use of such ingredients as standards to which components

were compared. However, these ingredients, which are powders, cannot be

identified through organoleptic testing. There is no ability to distinguish

these ingredients from other powder ingredients through gross organoleptic

analysis. Therefore, these ingredients can not be used as a standard on which a

scientifically valid method for identity testing can be based.

In your September 12, 2011 response letter, you stated that you will update the

FT-NIR analytical standards against which all new receptions of dietary

ingredients are compared so that all are based on reference samples for which

identity testing has been verified under the current CGMP regulations. You

stated that updates will be completed by purchasing standards, sending lots to

independent labs for TLC or HPLC identity tests, or consulting with experts. You

estimated that you will need up to six months to update the FT-NIR analytical

standards. You have also revised your SOP ((4), to require standards to be

verified by scientific methods or reference standards, not reliance on the

supplier's CoA.

You stated that you will provide a written update on the progress of your

corrections, confirm in writing when your updates are completed, keep records of

the methods used to verify the analytical standards for each ingredient, and

provide FDA with samples of these records. To the extent you hire an independent

lab to perform certain manufacturing operations for your firm, such as TLC or

HPLC identity testing, you are ultimately responsible for complying with the

requirements related to such manufacturing operations, even though you have

hired another person to perform that job task (72 Fed. Reg. 34753 at 34790, June

25, 2007). While your response appears to be adequate, your updates will be

verified at our next inspection or by review of documentation provided by your

firm.

Misbranded Dietary Supplements

Your PhytoBalance dietary supplement is misbranded within the meaning of section

403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because your product is fabricated

from two or more ingredients but the label fails to declare the common or usual

name of each ingredient. For example:

· Your label fails to declare the sub-ingredients of the vegetable

capsules used to manufacture this product [21 CFR 101.4((2)]. The requirement

to list component ingredients (or " sub-ingredients " ) may be met by either

parenthetically listing the component ingredients after the common or usual name

of the multi-component ingredient, or by listing the component ingredients

without listing the multi-component ingredient itself. Under the first

alternative, the component ingredients must be listed in descending order of

predominance within the multi-component ingredient; and under the second

alternative, the component ingredients must be listed in descending order of

predominance in the finished food [21 CFR 101.4((2)].

· Your label fails to declare the common or usual name of each botanical

ingredient as required by 101.4(h). In accordance with 21 CFR 101.4(h), the

common or usual name of ingredients of dietary supplements that are botanicals

(including fungi and algae) shall be consistent with the names standardized in

Herbs of Commerce, 1992 edition. Furthermore, the listing of these names on the

label shall be followed by statements of the Latin binomial name of the plant,

in parentheses, except that this name is not required when it is available in

the reference entitled Herbs of Commerce, for the common or usual name listed on

the label, and when required, the Latin binomial name may be listed before the

part of the plant [21 CFR 101.4(h)(2)]. Specifically, your label lists the

ingredients " dioscorea (wild yam) extract (root) " and " glycyrrhiza (licorice)

extract (root). " " Dioscorea " and " glycyrrhiza " are not appropriate common or

usual names. If a Latin binomial name is used, it should be listed

parenthetically after the common or usual name. In addition, you parenthetically

list the name " wild yam. " According to Herbs of Commerce, " wild yam " is the

standardized common name for Dioscorea villosa L. However, based on your

records, PhytoBalance is made using ((4)

The above violations are not intended to be an all-inclusive list of violations

that exist in connection with your products and their labeling. It is your

responsibility to ensure that your products meet all of the requirements of the

Act and its implementing regulations. Failure to promptly correct the violations

specified above may result in enforcement action without further notice. Such

action may include, but is not limited to, seizure and injunction.

Please notify this office in writing within 15 working days from your receipt of

this letter as to the steps you have taken to correct the above-listed

violations and to prevent similar violations. Your response should include any

documentation necessary to show that correction has been achieved. If you cannot

complete all corrections within 15 working days, please state the reason for the

delay and the date by which the corrections will be made.

Please address your reply to the U.S. Food and Drug Administration, One Montvale

Avenue, Stoneham, MA 02180, Attention: Todd Maushart, Compliance Officer. If

you have any questions about the content of this letter, please contact: Todd

Maushart at .

Sincerely,

/S/

Mutahar S. Shamsi

District Director

New England District

Cc:

Mr. Pierre Fitzgibbon

CEO

Atrium Innovations, Inc.

1405 Boulevard du Parc-Technologique

Quebec City, Quebec

Canada

G1P 4P5

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com<www.mraclinicalresearch.com/>

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