PreMark Health Science, Inc. – FDA Warning Letter, Apr 24, 2014

The FDA inspected PreMark Health Science, Inc. from April 15-24, 2014, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Key violations include: 1. **Failure to conduct identity testing on dietary ingredients** (e.g., Soy Isoflavones, Zinc Citrate) prior to use, as required by 21 CFR 111.75(a)(1)(i). The firm's proposed testing method lacked scientific validation and specific ingredient lists, and no investigation was conducted for products manufactured when the testing equipment was inoperable. 2. **Failure to establish laboratory control processes** for selecting non-compendia reference materials, lacking criteria for characterization (21 CFR 111.315(d)). 3. **Failure to establish specifications** for components, labels, packaging, and labeling of dietary supplements (21 CFR 111.70(a), (b), (d), (g)). 4. **Failure to prepare and follow written Master Manufacturing Records (MMRs)** for each unique formulation and batch size, as required by 21 CFR 111.205(a) and 111.210. 5. **Failure to create complete Batch Production Records