Zing Brothers LLC – FDA Warning Letter, Aug 24, 2022

The FDA inspected a manufacturing facility at 2030 N Redwood Rd, Suite 70, Salt Lake City, UT, on August 17, 18, 22, and 24, 2022, and reviewed labels for products (b)(4) and (b)(4). The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 111, leading to the classification of products as adulterated and misbranded.

Key violations include: - **Adulterated Dietary Supplements (21 CFR Part 111):** - Failure to establish specifications for manufacturing processes, including component (identity, purity, strength, composition, contamination limits) and finished product specifications (21 CFR 111.70(a), (b), (e)). - Failure to establish and follow written procedures for quality control operations, material review, and disposition decisions (21 CFR 111.103). - Failure to prepare and follow Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)). - Batch Production Records (BPRs) lacked complete information, including equipment identity, cleaning dates, unique identifiers for components/packaging/labels, actual/theoretical yield, packaging/labeling documentation, and quality control