Sterling USA Neutraceutical Lab, LLC – FDA Warning Letter, May 21, 2012

On November 16, 2012, the FDA issued a Warning Letter to Sterling USA Neutraceutical Lab, LLC, following an inspection from May 2 to May 21, 2012. The inspection revealed significant violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) for dietary supplements, rendering their products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to prepare and follow written master manufacturing records for each unique dietary supplement formulation (21 CFR 111.205(a)), specifically for (b)(4) Capsules and (b)(4) Capsules. 2. Failure to prepare complete batch production records for each batch manufactured (21 CFR 111.255), including missing records for (b)(4) Capsules and incomplete records for (b)(4) lacking essential information like batch numbers, equipment cleaning dates, component identifiers, weights/measures, actual/theoretical yields, finished product specifications, and documentation of performance and quality control reviews at the time of execution (21 CFR 111.260). 3. Failure to establish specifications for identity, purity, strength, and composition for components and in-process production (21 CFR 111.70(a), (b), (c