FDA WARNING_LETTER - Stat Rx USA - February 15, 2012

The FDA issued a Warning Letter to Stat Rx USA, LLC, following a February 7-15, 2012, inspection of their pharmaceutical manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 C.F.R. Parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to ensure returned drugs meet quality standards before redistribution (21 C.F.R. § 211.204):** The firm lacked adequate written procedures for evaluating returned drugs for quality, integrity, and exposure to adverse conditions or tampering. The provided draft SOP was insufficient, and the firm's response did not include the revised procedure. 2. **Lack of a written stability testing program (21 C.F.R. § 211.166(a)):** The firm did not have data or scientific evaluation to support the stability of repackaged products, particularly concerning the omission of desiccants present in original packaging and the assigned expiration dates. The firm's claim of being a "pharmaceutical tech" was rejected; they are considered a drug manufacturer subject to CGMP. 3. **Failure to retain appropriately identified reserve samples (21 C.F.R. § 211.170(b)):** Stat Rx USA did not retain reserve samples of repack