West Coast Laboratories, Inc. – FDA Warning Letter, Oct 24, 2023

The FDA issued a Warning Letter to a facility in Gardena, CA, following an inspection from October 3-24, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering Calcium Pyruvate, Chromium Picolinate, and CalComplex products adulterated.

Key violations include: 1. **Lack of Identity Testing:** Failure to conduct identity testing for dietary ingredients like (b)(4), Naticol HPMG, Aquamin F, and Calcium Pyruvate before use, as required by 21 CFR 111.75(a)(1)(i). 2. **Inadequate Component Specifications:** Failure to establish specifications for purity, strength, and composition of components like (b)(4), Naticol HPMG, Aquamin F, and Calcium Pyruvate, violating 21 CFR 111.70(b)(2). 3. **Release of Out-of-Specification Product:** Quality control approved and released Calcium Pyruvate Lot 150822 despite an out-of-specification calcium result for a component, violating 21 CFR 111.123(b)(1). 4. **Premature Component Use:** Components (Aquamin F Lot (b)(4), Calcium Pyruvate Lot (b)(4)) were used in manufacturing before