GAR Laboratories Inc – FDA Warning Letter, Jul 29, 2010

On December 6, 2010, the FDA issued a Warning Letter to GAR Laboratories, Inc., following a July 13-29, 2010 inspection. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). Additionally, the drug product (b)(4) was found to be misbranded under 21 U.S.C. § 352(a) due to misleading labeling regarding "herpes simplex infection."

Key violations include: 1. **Inadequate Quality Control Unit (QCU):** Failure to establish an adequate QCU with authority to approve/reject materials and products (21 C.F.R. § 211.22(a)). The firm reworked failing lots without documented justification, against QCU recommendations. 2. **QCU Approval of Procedures/Specifications:** QCU did not approve formulation and specification changes made by R&D (21 C.F.R. § 211.22(c)). 3. **QCU Review of Records and Investigations:** Failure of QCU to review and approve production records before release and distribution, and lack of documented investigations into Out-of-Specification (OOS) results for drug products, microbiological results, and deionized water system