Vita-Herb Nutriceuticals, Inc. 10/20/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Los Angeles District 19701 Fairchild Irvine, California 92612-2506 Telephone (949) 608-2900 Fax (949) 608-4415

 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

October 20, 2010

W/L 07-11

Mohamed Bing Baksh, President/CEO
Vita-Herb Nutriceuticals, Inc.
1012 Segovia Circle
Placentia, CA 92870-1944

Dear Mr. Baksh:

On May 18th through June 29th, 2010, the U.S. Food and Drug Administration (FDA) inspected your firm located in Placentia, CA. Your film manufactures, packages, labels, and holds dietary supplements. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP), 21 CFR Part III for the Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements.

The inspection revealed that your (b)(4) Cod Liver Oil capsules, (b)(4) capsules, and (b)(4) Omega-3 DHA capsules products manufactured in your facility, are 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 current good manufacturing practice regulations for dietary supplements. These observations were presented to you in a FDA-483 at the conclusion of our' inspection on June 29, 2010.

The inspection revealed the following deficiencies:

1. Your firm failed to conduct testing of each finished batch of dietary supplement to determine whether such dietary supplement met established product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c). You must establish product specifications for each dietary supplement you manufacture (21 CFR 111.70(e)), and determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with testing requirements in 21 CFR 111.75(c).

The inspection disclosed that batch records for the following released finished products lacked finished product testing to verify the identity, purity, strength, and composition:

i. (b)(4) Cod Liver Oil capsules, (b)(4)-count bottles), lots (b)(4) and (b)(4);

ii. (b)(4) Bombyx Mori capsules for male performance, lots (b)(4) (bulk packaged), (b)(4) (one-count blister cards), (b)(4) (one-count blister cards) and (b)(4) (bulk packaged +one-count blister cards);

iii. (b)(4) Omega-3 DHA capsules (b)(4)-count bottles), lot (b)(4).

Pursuant to 21 CPR 111.75(c)(1), you must either verify that every finished batch of these products meets your product specifications or you must identify a subset of finished batches to test using a sound statistical sampling plan.

We reviewed your response dated July 20, 2010, and have concluded that it is inadequate. Your letter stated that you will increase the scope of testing "to capture a wider slice of the products manufactured," but you did not provide documentation that the above batches had finished product testing conducted and did not provide documentation on how you plan to ensure finished product testing is conducted for future batches.

2. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use, to comply with 21 CPR 111.75(a)(1)(i).

Specifically, your firm uses a (b)(4) cod liver oil, (b)(4) vitamin (b)(4) oil, and (b)(4) oil in your (b)(4) Cod Liver Oil capsules; b) bombyx mod proprietary blend in your (b)(4) capsules; and c) DHA oil, (b)(4) oil and (b)(4) oil in your (b)(4) Omega-3 DHA capsules, but your firm does not perform an identity test or examination on any of the dietary ingredients used in such dietary supplements. Although your firm performs microbiological tests for these dietary ingredients, such testing is not appropriate to indicate the identity of such ingredients.

We reviewed your response dated July 20, 2010, and have concluded that it is inadequate. Your letter stated that you will increase the scope of testing, but you did not specify and submit supporting documentation on how you intend to ensure that you will verify the identity of each dietary ingredient used in these dietary supplements you manufacture.

3. Your film failed to approve and release from quarantine all components before they were used, as required by 21 CPR 111.120(e).

Specifically, your quality unit did not approve and release from quarantine the following dietary supplement ingredients before they were used in the manufacture of dietary supplement products.

i. (b)(4) Cod Liver Oil - Material#(b)(4) and (b)(4) was added to your (b)(4) product, Lot (b)(4) and (b)(4) on April 8, 2010 and April 19, 2010, respectively, before the ingredient was released on May 10, 2010.

ii. (b)(4) Beeswax - Material#(b)(4) was added to (b)(4) product, Lot (b)(4) on April 19, 2010, before the ingredient was released on May 10, 2010.

iii. Bombyx Mori Blend - Material#(b)(4) was added to your (b)(4) product, Lots (b)(4) and (b)(4) on January 7, 2010, before the ingredient was released on January 27, 2010.

iv. Bombyx Mori Blend - Material#(b)(4) was added to your (b)(4) product, Lot (b)(4) on April 6, 2010, before the ingredient was released on May 10, 2010.

v. DHA (b)(4) Oil - Material#(b)(4) and (b)(4)- Material#(b)(4) was added to your (b)(4) Omega-3 DHA product, Lot (b)(4) on December 9, 2009, before the ingredients were released on December 17, 2009 and December 29, 2009, respectively.

We reviewed your response dated July 20, 2010, and have concluded that it is inadequate. You have not committed to fully complying with the regulation by approving and releasing all components before they are used.

4. Your firm failed to include documentation, at the time of performance, in the batch production record, that quality control personnel approved and released, or rejected, the batch for distribution, including any reprocessed batch, to comply with 21 CPR 111.260(1)(3) and 21 CPR 111.123(a)(8). Specifically, our review of the following batch records for (b)(4) Bombyx Mori capsules for male performance indicate that your quality personnel did not document approval and release, or rejection, of the batch for distribution prior to release of the product for distribution.

 

Lot Number	Date Shipped	Date of QA Bill of Material	Date of QA Final Formula Review	Date of QA Final Record Review
(b)(4)	1/7/10	1/20/10	1/20/10	Bulk shipped, no packaging record for Final Record Review
(b)(4)	"1/19/09" printed, with actual ship date of 1/19/10	1/20/10	1/20/10	1/20/10
(b)(4)	4/6/10, 4/8/10, 4/14/10, 4/26/10	6/2/10	6/2/10	6/8/10
(b)(4)	5/11/10	No Bill of Material Review	No Final Formula Review	6/8/10

Your firm failed to include documentation, at the time of performance, in the batch production record, that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement, to comply with 21 CFR 111.260(1)(4) and 21 CPR 111.127(h). Specifically, our review of the following batch records below indicated that you only conducted a review of the batch records of finished dietary supplement products after the finished dietary supplements were released to your customers.

a.) (b)(4) Cod Liver Oil (b)(4)

Lot Number	Date Shipped	Date of QA Bill of Material Review	Date of QA Final Formula Review	Date of QA Final Record Review
(b)(4)	5/6/10, 5/10/10, 5/13/10	5/18/10	5/18/10	5/18/10
(b)(4)	4/28/10	5/18/10	5/18/10	5/18/10

 

b.) (b)(4) Omega-3 DHA

Lot Number	Date Shipped	Date of QA Bill of Material Review	Date of QA Final Formula Review	Date of QA Final Record Review
(b)(4)	12/28/09, 1/4/10	5/20/10	5/20/10	5/20/10

  

We reviewed your response dated July 20, 2010, and have concluded that it is inadequate. You have not committed to fully complying with the regulation because an "effort[] to decrease occurrences of this type" does not indicate that you will review the batch records and make a determination on the batch of product (e.g., approved and released or rejected) prior to it being released.

5. Lastly, our review of the inspection records collected during the inspection, specifically, the batch records for the DHA (b)(4) Capsules, Lot (b)(4), showed that you added (b)(4) per capsules of (b)(4) to the batch during blending to compensate for leaky capsules. However, your film failed to make and keep documentation of any material review and disposition decision and follow-up, as required by 21 CFR 111.140(b)(3). Specifically, you did not provide documentation of any material review and disposition decision and follow up for this deviation. Such documentation must meet the requirements of 21 CFR 111.140(b)(3), including an identification of the specific deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(i)] , a description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence [21 CFR 111.140(b)(3)(ii); an evaluation of whether or not the deviation or unexpected occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement [21 CFR 11.140(b)(3)(iii)]; the identification of the actions taken to correct, and prevent a recurrence of, the deviation or unanticipated occurrence [21 CPR 111.140(b)(3)(iv); an explanation of what you did with the component, dietary supplement, packaging, or label [21 CFR 111.140(b)(3)(v)]; and a scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected [21 CFR 111.140(b)(3)(vi)].

This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

Additionally, we note that there is 2 year expiration dating placed on product labels of (b)(4) Cod Liver Oil capsules and (b)(4) Omega-3 DHA capsules manufactured in your facility. Any expiration date you place on a product label should be supported by data. (See 72 FR 34752 at 34856; June 25, 2007). You should continue to work with your customers to provide supporting data for the expiration dates placed on the products you manufacture.

Please advise this office in wilting within 15 working days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.

Your response should be sent to:

Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612

If you have any questions about the content of this letter, please contact Mei-Chen (Jessica) Mu, Compliance Officer, at 949-608-4477.

Sincerely yours,
/S/
Alonza E. Cruse

District Director
 

 

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