# FDA WARNING_LETTER - GAR Laboratories Inc - July 29, 2010

Source: https://www.globalkeysolutions.net/records/warning_letter/gar-laboratories-inc/7c74ea72-66e6-4bf1-b0ec-8e507e1b46f2

> FDA WARNING_LETTER for GAR Laboratories Inc on July 29, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: GAR Laboratories Inc
- Inspection Date: 2010-07-29
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: 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

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- [Director](https://www.globalkeysolutions.net/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.globalkeysolutions.net/companies/gar-laboratories-inc/9ea7b326-5e84-4248-b07d-8e1748e09c59

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