Applied Polymer Systems, Inc. d/b/a APS Pharmaco – FDA Warning Letter, May 14, 2012

On September 27, 2012, the FDA issued a Warning Letter to Applied Polymer Systems, Inc. d/b/a APS Pharmaco following an inspection from May 7-14, 2012, at their Lindenhurst, NY facility. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to conduct identity testing for dietary ingredients prior to use (21 CFR 111.75(a)(1)(i)) for products like Raspberry Ketone 250 and Barley Sensoriay Green. 2. Failure to verify finished dietary supplement batches meet product specifications for identity, purity, strength, and composition (21 CFR 111.75(c)). 3. Failure to qualify suppliers by confirming the reliability of their Certificates of Analysis (COAs) (21 CFR 111.75(a)(2)(ii)(A)). 4. Absence of written Master Manufacturing Records (MMRs) for each unique formulation (21 CFR 111.205(a)), with provided formulas not meeting requirements. 5. Failure to prepare Batch Production Records (BPR