FDA WARNING_LETTER - Nature's Supplements, Inc. - January 23, 2020

The FDA inspected BioLife Nature's Supplements in Oceanside, CA, from January 13-23, 2020, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated. Additionally, product labels were found to be misbranded under section 403 of the Act.

Key CGMP violations include: 1. Failure to establish finished product specifications for identity, purity, strength, and composition for products like MRM Nutrition Neuro-Max II Nootropic and BioLife Nature's Supplements Vitami-Life. The company's proposed "testing" was deemed insufficient as it did not establish specific criteria. 2. Failure of quality control to ensure labels conform to specifications, with discrepancies found between Master Manufacturing Records (MMRs) and labels for products like Vitami-Life and Biotropic. 3. MMRs lacking required information, specifically representative labels or cross-references, for products such as Neuro-Max II Nootropic and Vitami-Life. 4. Failure to establish and follow written procedures for laboratory operations, including the use of specific analytical instruments and creation of reference standards.

Misbranding violations include: 1. Non-compliance with nutritional information presentation (21 CFR Part 101.36), such as incorrect headings ("Nutrition Facts" instead of "Supplement Facts"), improper nutrient order, and incorrect declaration of proprietary