FDA WARNING_LETTER - Long Island Pharmaceuticals LLC - July 03, 2014

The FDA inspected Long Island Pharmaceuticals, LLC's dietary supplement manufacturing facility from June 27 to July 3, 2014, finding serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to verify identity of dietary ingredients (21 CFR 111.75(a)(1)(i))**: The firm did not verify the identity of numerous dietary ingredients in products like (b)(4) and (b)(4). The firm's proposed random identity testing and rotating assay testing were deemed inadequate, as all dietary ingredients must be verified. 2. **Failure to verify finished product specifications (21 CFR 111.75(c))**: The firm did not test finished batches for identity, purity, strength, and composition, stating customers were responsible. Their plan to assay one active ingredient and conduct microbiological testing was deemed insufficient without further justification. 3. **Failure to implement quality control operations (21 CFR 111.65)**: The firm lacked overall quality control operations and responsibilities. 4. **Improper equipment maintenance (21 CFR 111.27(a)(3)(v))**: Equipment, specifically a (b)(