FDA WARNING_LETTER - GE PHARMA LLC - September 13, 2013

On August 26, 2014, the FDA issued a Warning Letter to GE Pharma LLC following an inspection from August 21 to September 13, 2013. The inspection revealed significant 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 (the Act).

Key violations include: 1. **Unapproved New Drug Violations:** The "Performa Test" product is marketed with therapeutic claims (e.g., "raise total and free testosterone levels," "helps blood sugar stabilization, boosting libido"), classifying it as an unapproved new drug under Section 201(p) of the Act. It is also misbranded under Section 502(f)(1) for lacking adequate directions for layperson use. 2. **Dietary Supplement CGMP Violations:** * Failure to identify quality control personnel and establish/follow written procedures for quality control operations, material review, and disposition decisions (21 CFR 111.12(b), 111.103, 111.140(b)(1)). GE Pharma, as a distributor, is ultimately responsible for ensuring CGMP compliance of products manufactured by contract manufacturers. * Failure