API MFG CITED FOR OOS AND MICROBIOLOGICAL ISSUES (B. cepacia) -- REFERENCES RECENT PDA J. PHARM SCI & TECH 1. Your firm failed to have an adequate out-of-specification (OOS) procedure to conduct thorough and scientifically sound investigations including corrective actions. For example, the OOS report number (b)(4) for lot (b)(4) of Simethicone Emulsion USP … [Read more...]