FDA WARNING_LETTER - Somalabs, Inc - December 12, 2018

The FDA inspected SomaLabs, Inc.'s dietary supplement facility from November 15 to December 12, 2018, finding significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplement products adulterated. Additionally, their "ThermoCaps" product was found to be misbranded under section 403 of the Act.

Key CGMP violations include: 1. Failure to verify finished dietary supplement batches meet product specifications for identity, purity, strength, and composition (21 CFR 111.75(c)). The firm lacked documentation for its testing program's scientific rationale. 2. Failure to confirm the identity of other components and meet specifications, specifically by not qualifying suppliers or establishing the reliability of their Certificates of Analysis (COAs) (21 CFR 111.75(a)(2)). 3. Quality control personnel failed to reject components or finished products that did not meet specifications, or conduct material reviews for out-of-specification results (21 CFR 111.77(a), 111.113(a)(1), 111.113(b)(2)). Examples included green tea and finished products with incorrect weights or ingredient levels. 4. Failure to prepare and follow complete written Master Manufacturing Records (MMRs) for each unique formulation and batch