True^^^Adulterated Dietary Supplements
In addition, even if your product listed above was not an unapproved new and misbranded drug, it and the other products distributed under your firm's label would be adulterated dietary supplements within the meaning of section 402(g)(1) of 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 the requirements set forth in the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111, (21 CFR Part 111).
Based on the records reviewed during this inspection, your firm sends raw materials to contract manufacturers who manufacture (b)(4) dietary supplements including Jack3d, OxyElite Pro, Prime, and Super Cissus various packaging configurations and flavors, and then return the finished products to USPlabs for distribution under your firm's own label. As a dietary supplement distributor that contracts with another contract manufacturer to manufacture dietary supplement under your firm's name, your firm is ultimately responsible for complying with the requirements relating to manufacturing operations [see 72 Fed. Reg. 34752, 34790; June 25, 2007]. Your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution.
Furthermore, we received your firm's written responses with attachments from Lorena Macias, Quality Assurance and Quality Control Director, dated March 14 and June 1, 2012, to the Form FDA 483 (inspectional observations) that was issued to your firm at the conclusion of the inspection on February 21, 2012. We respond to your firm's written responses, below.
Specific violations are as follows:
1. Your firm failed to establish and follow written procedures, as required by 21 CFR 111.553, for the review and investigation of product complaints, as required by 21 CFR 111.560(c). Specifically, your firm's revised procedures related to product complaints in your written procedures entitled "Consumer Complaints (QA-020)" submitted in your March 14, 2012 response to the FDA-483 do not account for the requirements of 21 CFR 111.560(c) in that the procedures do not provide written instructions that quality control personnel review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed.
2. Your firm failed to establish product specifications for the identity and purity of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). For each dietary supplement you have manufactured, it is your firm's responsibility to establish product specifications 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 111.70(e). As stated in the final rule (72 FR 34752 at 34837; June 25, 2007), "the manufacturer has the responsibility to determine what types of contamination are likely or certain to contaminate a given product and to determine what types of tests to conduct and when to test for such contamination."
Based on information in your supplier's COAs for certain raw materials, chemicals and pesticides are likely or certain to contaminate these raw materials; however, your firm did not establish specifications related to chemicals and pesticides for products that contain these raw materials, including Jack3d Lemon Lime, OxyElite Pro, and Prime.
Your firm's March 14 and June 1, 2012 responses, including attachments, were reviewed and determined to be inadequate. The product specification sheets you provided for many of your dietary supplement products, including Jack3d Lemon Lime, OxyElite Pro, and Prime were inadequate because the product specifications sheets failed to include identity and purity specifications for these products. You also failed to include any specifications related to chemical and pesticides listed on these sheets.
3. Your firm's quality control operations for the master manufacturing record (MMR) failed to include reviewing and approving all master manufacturing records and all modifications to the master manufacturing records, as required by 21 CFR 111.123(a)(1). Specifically, our review of your Jack3d Master Formula revealed that it was not approved by your quality control operations.
Your firm's March 14 and June 1, 2012 responses were reviewed and determined to be inadequate. Your response included your firm's Standard Operating Procedures (SOP) # QA-036, Finished Dietary Supplement Formula and MMR Approval, which indicates that your contract manufacturers submit all product formulas and master manufacturing records for review and approval. However, your response did not include an MMR reviewed and approved for Jack3d.
4. Your firm did not 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 supplies its contract manufacturer with raw materials, including dietary ingredients, which are used by another manufacturer in the manufacture of your firm's dietary supplements; however, our investigators found that you did not conduct at least one test or examination to verify the identity of such dietary ingredients, as required by 21 CFR 111.75(a)(1).
Instead, your firm relied on Certificates of Analysis (COA) from your suppliers.
A COA from a supplier may not be used to verify the identity of any component that is a dietary ingredient [see 21 CFR 111.75(a)]. Specifically, your firm supplies (b)(4) dietary ingredients to its contract manufacturer for the use in production of two of your own label dietary supplement products, Jack3d and OxyELITE Pro. Your firm routinely receives and accepts (b)(4) incoming dietary ingredients into its facility with accompanying Certificates of Analysis and does not verify the identity of these dietary ingredients before sending them to the contract manufacturer for use in the manufacture of your own label dietary supplement products.
Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements in 21 CFR 111.75(a)(1)(ii), and FDA has granted such petition. Your firm has not petitioned FDA for such an exemption.
Furthermore, if you would like to rely on a certificate of analysis from the supplier of the components (other than dietary ingredients) you receive for use in your firm's dietary supplement products to confirm the identity of such components, you must comply with the requirements in 21 CFR 111.75(a)(2)(ii).
5. Your firm's quality control personnel failed to approve or reject all processes, written procedures, controls, tests and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). For example, your firm's quality control personnel did not approve testing methods for (b)(4)
Your firm's March 14 and June 1, 2012 responses were reviewed and determined to be inadequate. You indicated that your Quality Assurance and Quality Control Director will review all test methods, but you did not provide any supporting documentation that any test methods were actually reviewed by your Director.
6. Your firm's master manufacturing record (MMR) for the dietary supplement product Jack3d failed to identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in your MMR, as required by 21 CFR 111.205(b)(1). In addition, your firm's MMR for this product failed to establish controls and procedures to ensure that each batch of dietary supplements that you manufacture meets the specifications identified, as required by 21 CFR 111.205(b)(2)
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