Comment · Wed, June 22, 2022 · ND Owner
MPMD Video Addressing the ND Lab Test Results on Turkesterone
What they were answering
Freeeecurry · -9 points
That’d be dumb to conclude considering nutracap is owned by a very wealthy individual who would indeed have access to turk. Plus you DO NOT want to get on his bad side. He will sue you into bankruptcy. ND should have conducted a proper chain of custody as he claimed chromadex has a testing standard for Turk.
u/MisterYouAreSoDumb · ND Owner
This Nutracap?
Your dietary supplement products are adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements found in 21 CFR Part 111. During the inspection, we observed the following significant violations of the CGMP regulations for dietary supplements:
Your quality control personnel also failed to perform operations that ensure your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. During the inspection, a review of the finished product label and BPR for (b)(4), lot number (b)(4) found that the ingredients listed on the product label are not consistent with the Batch Production Record (BPR). The BPR indicates the lot was manufactured with the ingredients (b)(4). However, these ingredients are not declared on the product label you use for this product.
You failed to determine whether component specifications other than identity established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Under 21 CFR 111.75(a)(2), you must either conduct appropriate tests or examinations or rely on a certificate of analysis (COA) from the supplier of the component that you receive, provided that the COA meets specific requirements. You receive dietary ingredients, including botanical ingredients from domestic and international suppliers, and you do not typically perform any heavy metal testing, choosing instead to rely on the results of your suppliers’ COAs. However, you may only rely on a COA from a supplier of the component if the following conditions are met: (A) you first qualify the supplier by establishing the reliability of the supplier's COA through confirmation of the results of the supplier's tests or examinations; (B) the COA includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) you maintain documentation of how you qualified the supplier; (D) you periodically reconfirm the supplier's COA; and (E) your quality control personnel review and approve the documentation setting forth the basis for qualification (and re‐qualification) of any supplier. You have not qualified any suppliers by confirming the reliability of the COA.