FDA WARNING_LETTER - NatureLab Corp. - October 22, 2021

The FDA issued a Warning Letter to a dietary supplement manufacturer following inspections on October 18-22, 2021, a follow-up to an April 8-May 6, 2021 inspection. The letter identifies serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering the dietary supplements adulterated under 21 U.S.C. 342(g)(1).

Key violations include: 1. **Failure to establish specifications (21 CFR 111.70(a))**: The firm lacked written specifications for components (identity, purity, strength, composition, contamination limits), in-process materials, and finished products for multiple dietary supplements. The provided "Certificate of Quality" was deemed insufficient due to lack of supporting documentation and scientific validity. 2. **Inadequate Master Manufacturing Records (MMRs) (21 CFR 111.205(a), 111.210)**: The firm failed to prepare and follow complete MMRs for various products and batch sizes. MMRs lacked crucial information such as strength/concentration of ingredients, complete component lists, accurate weights, theoretical yields, packaging descriptions, and detailed manufacturing instructions. 3. **Incomplete Batch Production Records (BPRs) (21 CFR 111.255(b), 11