Sterling USA Neutraceutical Lab, LLC 11/16/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
November 16, 2012 W/L 06-13
Mr. Fahim Rahman
Marketing Director and Co-Owner
Sterling USA Neutraceutical Lab, LLC
6739 San Fernando Rd.
Glendale, CA 91201-1704
Dear Mr. Rahman:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 6739 San Fernando Rd., Glendale, CA from May 2 through May 21, 2012. Our investigators found significant violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause your 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. You may find the Act and the FDA’s regulations through links in the FDA’s home page at http: www.fda.gov
The inspection revealed the following violations:
1) Your firm failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplements that you manufacture as required by 21 CFR 111.205(a). Specifically, you did not establish a written master manufacturing record for your (b)(4) Capsules or (b)(4) Capsules in accordance with 21 CFR 111.210.
2) Your firm failed to prepare a complete batch production record every time you manufactured a batch of a dietary supplement as required by 21 CFR 111.255. Specifically:
- You failed to create a batch production record for your (b)(4) Capsules (b)(4).
- The batch production record for your (b)(4) failed to contain the following information as required in 21 CFR 111.260:
a. The batch, lot, or control number that you assign in accordance with § 111.415(f) for each lot of packaged and labeled dietary supplements [21 CFR 111.260(a)(2)(i)].
b. The date and time of maintenance, cleaning and sanitizing of equipment used in producing the batch or a cross reference to the records [21 CFR 111.260(c)].
c. The unique identifier that you assigned to each component, packaging and label used [21 CFR 111.260(d)].
d. The identity and weight or measure of each component used [21 CFR 111.260(e)].
e. A statement of the actual yield and percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]. Specifically, the actual and theoretical yields after the blending and encapsulation operations were not listed on the batch records.
f. Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g) [21 CFR 111.260(i)].
g. Documentation of the manufacture of the batch at the time of performance [21 CFR 111.260(j)]. Specifically, the following information was not documented in your batch production records at the time of performance:
i. The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
ii. The initials of the person responsible for verifying the addition of components into a batch [21 CFR 111.260(j)(2)(iv)].
h. Documentation at the time of performance of packaging and labeling operations [21 CFR 111.260(k)]. Specifically, the following information was not documented:
i. An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(1)].
i. Documentation at the time of performance that quality control personnel reviewed the batch product record, including a review of any monitoring operations required under Subpart E of Part 111 [21 CFR 111.260(l)(1)(i)].
3) Your firm failed to establish specifications for identity, purity, strength, and composition for each component that was used in the manufacture of your dietary supplement products, (b)(4) Capsules, (b)(4) and (b)(4) Capsules, (b)(4), as required by 21 CFR 111.70(a), in accordance with 21 CFR 111.95. Specifically:
- For each component that you use in the manufacture of a dietary supplement, you failed to establish specifications for the identity, purity, strength, and composition of dietary supplements manufactured using the components are met and for limits on those type of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(b)].
- You did not establish specifications for the in-process production, as required by 21 CFR 111.70(c).
Once you have established the above specifications, you must determine whether the specifications have been met as required by 21 CFR 111.75(c).
4) Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Your firm either receives dietary ingredients from your customers, or you provide them for your customers. During the inspection you did not conduct identity testing on any of the dietary ingredients used in the (b)(4) Capsules, (b)(4) and (b)(4) Capsules, (b)(4) finished products.
5) Your firm failed to qualify suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, your firm does not qualify your suppliers prior to using components received by them to use in the manufacture of dietary supplements. The inspection revealed that your firm does not always receive certificates of analysis for components from your suppliers, nor do you establish the reliability of suppliers’ certificates of analysis that accompany materials received from their customers.
We have reviewed your response to the Form FDA-483, dated June 8, 2012, and have found it to be inadequate. You have not provided sufficient information to demonstrate that you have implemented your corrective actions. We will verify the adequacy of your corrective actions during our next inspection.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and your products 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.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including costs related to reinspection. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to reinspection.
Please respond in writing within 15 working days from your receipt of this letter. Your response should include the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. 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:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Dr. William Vitale, Compliance Officer, at 949-608-2919.
Alonza E. Cruse, Director
Los Angeles District
Cc: Ms. Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, CA 95899-7435