FDA WARNING_LETTER - APP Pharmaceuticals, LLC. - July 08, 2011

This FDA Warning Letter (NYK-2012-14) to APP Pharmaceuticals, LLC, dated July 29, 2011, details significant Current Good Manufacturing Practice (CGMP) violations observed during a June 13-July 8, 2011 inspection of their Grand Island, NY facility. These violations render their drug products adulterated.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate unexplained discrepancies, such as insects in aseptic filling areas and finished products (e.g., delayed supplier audits, insufficient corrective actions), recurring missing labels on vials (failure to identify trends), and out-of-specification (OOS) assay results for Heparin Lock Flush (e.g., incomplete investigation, failure to extend to other batches). 2. **Lack of Microbiological Contamination Prevention (21 CFR 211.113(b)):** Inadequate written procedures for preventing contamination, including improper documentation of process simulation events (e.g., destroyed vials without rationale) and observed poor aseptic techniques by operators (e.g., rapid movement, shaking stopper bags), contributing to multiple media fill failures. 3. **Failure to Follow Complaint Procedures (21 CFR 211.198):** Not performing initial impact assessments for approximately 100 customer complaints (e.g