FDA WARNING_LETTER - Sandoz Incorporated - August 04, 2011

The FDA issued a Warning Letter to Novartis International AG on November 18, 2011, following inspections of its Sandoz pharmaceutical manufacturing facilities in Broomfield, Colorado; Wilson, North Carolina; and Boucherville, Quebec, Canada, conducted from April to August 2011. The inspections revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering drug products adulterated.

Key violations at Sandoz Canada Inc. (Boucherville) included: - **Microbiological Contamination Prevention (21 CFR § 211.113(b)):** Insufficient media fill studies with inconsistent and inaccurate reconciliation of filled vials, a repeat observation from July 2009. - **Investigation of Batch Failures (21 CFR § 211.192):** Inadequate investigation into crystallization of (b)(4) Injectable, with 62.5% of reviewed lots showing crystals, and failure to determine the root cause or implement effective corrective actions. This was also a repeat observation. - **Component Testing (21 CFR § 211.84(d)(2)):** Reliance on supplier's Certificate of Analysis for stoppers without adequate vendor qualification or routine endotoxin testing, a repeat observation. - **Field Alert Report (FAR) Violations (21 CFR §