FDA WARNING_LETTER - Nutra Solutions USA, Inc. - April 09, 2019

On March 21, 25, 28, 29, and April 3, 5, and 9, 2019, the FDA inspected a dietary supplement manufacturing facility at 1019 Grand Boulevard, Deer Park, NY. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), causing products like (b)(4) and (b)(4) to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to establish product specifications for identity and purity of finished dietary supplement batches (21 CFR 111.70(e)). 2. Failure to establish identity specifications for each component used in manufacturing (21 CFR 111.70(b)(1)). 3. Quality control operations failed to determine if in-process specifications were met, lacking documentation for investigations or deviation reports for non-conformances (21 CFR 111.123(a)(6)). 4. Failure to examine packaging and labels before operations to ensure conformity with master manufacturing records (21 CFR 111.410(c)). 5. Master manufacturing records (MMR) failed to include all required information (21 CFR 111