FDA WARNING_LETTER - NutraCap Labs LLC - December 11, 2019

The FDA issued a Warning Letter to NutraCap Labs, LLC following an inspection from November 5 to December 11, 2019, which identified serious violations of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 111 for dietary supplements. The firm's dietary supplements were deemed adulterated due to significant Current Good Manufacturing Practice (CGMP) deficiencies. Key violations included failure to approve or reject processes and specifications affecting product identity, purity, strength, or composition (21 CFR 111.105(a)), and quality control personnel failing to ensure manufacturing operations met quality and labeling standards (21 CFR 111.105). The firm also failed to verify component specifications or properly qualify suppliers for Certificates of Analysis reliance (21 CFR 111.75(a)(2)), and Master Manufacturing Records lacked representative labels (21 CFR 111.210(g)). Additionally, obsolete or incorrect labels were not suitably disposed of (21 CFR 111.415(h)). A critical finding was that certain products contained 2-amino-5-methylheptane (DMHA), an unsafe food additive, rendering them adulterated under sections 402(a)(2)(C)(i) and 409(a) of the Act. The FDA reviewed the firm's January 2, 2020, response but found proposed corrective actions, such as new SOPs, insufficient due to a lack of implementation documentation or clarity. The company must take prompt action to correct all violations and respond within fifteen working days with detailed corrective steps and supporting documentation to avoid further regulatory action, including seizure, injunction, and reinspection fees.