Inspections, Compliance, Enforcement, and Criminal Investigations
Pinnacle Labs International, Inc. 6/19/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
UNITED PARCEL SERVICE
June 19, 2014
W/L 22 - 14
Roy O. Day, Jr.
Pinnacle Labs International, Inc.
284 Industry Way
Upland, CA 91786
Dear Mr. Day:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 284 Industry Way, California on April 11 to May 1, 2013. During the inspection, our investigators found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). 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 they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements.
FDA has also reviewed the labels for several of your products and has determined that these products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. § 343] in that these labels fail to include required information. You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
Dietary Supplement CGMP Violations
1. Your firm failed to verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.75(c). Specifically, you did not verify that your finished batch of the dietary supplement met product specifications for the following:
- (b)(4) (lot (b)(4))
- (b)(4) capsules (lot (b)(4))
- (b)(4) capsules (lot (b)(4))
In your written response, dated May 17, 2013, you state that your firm will monitor documentation more closely. You also state that you have revised your Batch Production Records to provide greater clarity for review, and that you plan to have quality control personnel review all critical documents either before or after completion of a specific process or manufacturing stage. We find that your response is inadequate because it does not address the requirement to verify that your product meets its established specifications as described in 21 CFR 111.75(c). Please note that under 21 CFR 111.75(c)(2), you must conduct appropriate tests or examinations to determine compliance with established specifications.
2. 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) (except in situations where a firm successfully petitions FDA for an exemption from this requirement, pursuant to 21 CFR 111.75(a)(1)(ii)). Specifically, your quality control personnel did not review and approve the results of identity tests conducted by a contract laboratory on dietary ingredient components prior to their use in the manufacture of dietary supplements:
- (b)(4) powder, lot (b)(4), was used in the manufacture of (b)(4) lot (b)(4), from 03/24/13-03/27/13. However, the identity test results from the contract laboratory were not received until 04/09/13. Your firm used the raw material despite it being only a 41.0% match to your contract laboratory's standard.
- (b)(4) extract, lot (b)(4), was used in the manufacture of (b)(4) dietary supplement, lot (b)(4), from 03/13/13- 04/15/13. However, the identity test results from the contract laboratory were not received until 04/23/13.
We have reviewed your response letter, dated May 17, 2013, and have determined your response to be inadequate. You state that you commit to retroactively reviewing and notating on the batch production record acceptance of the identity tests conducted by your contract laboratory for certain products that have already been manufactured. You also state that in the future you intend to comply with 21 CFR 111.75, and that “[i]f any identity test is missing [you] intend to request that test document before using the ingredient or send a sample of the ingredient to [your] test laboratory.” To the extent that your response indicates a plan to rely on a certificate of analysis to verify the identity of your dietary ingredients, please note that such reliance on a certificate of analysis is not permitted under 21 CFR 111.75(a)(1)(i). We would also like to emphasize that review and approval of identity tests of incoming dietary ingredients has to be completed prior to their use in the manufacture of dietary supplements, and not retroactively.
3. Your firm failed to confirm the identity of components that are not dietary ingredients and to determine whether other applicable component specifications had been met, as required by 21 CFR 111.75(a)(2). You must do this either by conductingappropriate tests or examinations, or by relying on a certificate of analysis from a supplier after qualifying the supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s test or examinations, as further required by 21 CFR 111.75(a)(2). Specifically, your firm relies upon supplier certificates of analysis to confirm the identity of the non-dietary ingredient components used in the manufacture of your dietary supplements, such as silicon dioxide; however your firm has failed to qualify the supplier(s), as required by 21 CFR 111.75(a)(2)(ii)(A).
In your written response dated May 17, 2013, you state that you will have your suppliers complete a Quality Survey Form. We find this response to be inadequate because having your suppliers complete a Quality Survey Form does not satisfy the requirement to qualify your suppliers through confirmation of the results of the suppliers’ tests or examinations, as set forth in 21 CFR 111.75(a)(2)(ii)(A).
4. Your batch production records (BPR) did not include several elements that are required by 21 CFR 111.260. Specifically, your BPR (b)(4) (lot (b)(4)) dietary supplement did not include the following required information:
- The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)]. Specifically, the identity of the blender was not listed on the BPR.
- The unique identifier that you assigned to each component used [21 CFR 111.260(d)]. Specifically, your BPRs lack a unique identifier for the following components: (b)(4) among others.
- A statement of the actual yield at appropriate phases of processing [21 CFR 111.260(f)].
- Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g) [21 CFR 111.260(i)].
- Documentation, at the time of performance, of the manufacture of the batch [21 CFR 111.260(j)]. Specifically, the following information was not documented in your BPRs at the time of performance:
- The initials of the person responsible for weighing or measuring each component used in the batch [21 CFR 111.260(j)(2)(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)];
- The initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)].
- Documentation at the time of performance that quality control personnel reviewed the BPR, including review of any monitoring operations [21 CFR 111.260(l)(1)(i)]. Specifically, your “Capsuling Weight Sheet(s)” was not signed and dated by your quality control personnel.
- Documentation at the time of performance that quality control personnel reviewed the results of any tests and examinations [21 CFR 111.260(l)(1)(ii)]. Specifically, you distributed this product prior to quality control personnel receiving, reviewing and approving finished product microbial test results.
- Documentation at the time of performance that quality control personnel approved and released, or rejected, the finished batch for distribution [21 CFR 111.260(l)(3)].
In your written response dated May 17, 2013, you state that you will incorporate in-process checks and train employees to complete all BPRs. However, you did not provide us with any BPRs to review to determine if you are complying with these requirements. We will verify your corrective action at our next inspection.
Misbranded Dietary Supplements
1. Your (b)(4) product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the product label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product.
2. Your (b)(4) and (b)(4) products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
3. Your (b)(4) and (b)(4) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare all ingredients by their common or usual name. Specifically, both products are manufactured as capsules, but the labels fail to declare the capsule ingredients. In addition, (b)(4) product label declares (b)(4) as ingredients; however these are not the common or usual names for these dietary ingredients.
4. Your (b)(4) product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the label fails to identify the parts of the plants from which some of the botanical dietary ingredients were derived in accordance with 21 CFR 101.4(h)(1). For example, your product label does not list the part of the plant from which (b)(4) were derived.
5. Your (b)(4), (b)(4) (Original Formula) and (b)(4) products are misbranded within the meaning of 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that they fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
The above violations are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. You should take prompt action to correct the violations cited in this letter and to prevent their reoccurrence. Failure to do so may result in legal action without further notice, including seizure or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be sent to:
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 Jessica Mu, Compliance Officer, at 949-608-4477.
Alonza E. Cruse
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue - MS 7602
P.O. Box 997435
Sacramento, California 95899-7435
Attn: FDA Correspondence