FDA WARNING_LETTER - Novartis International AG - August 04, 2011

FDA issued a Warning Letter to Novartis International AG following inspections from April to August 2011 at its Sandoz facilities in Broomfield, Colorado; Wilson, North Carolina; and Boucherville, Quebec, Canada. The inspections revealed significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Parts 210 and 211), rendering drug products adulterated. Additionally, Sandoz Canada Inc. failed to submit NDA Field Alert Reports (FARs) as required by 21 CFR § 314.81(b)(1)(ii).

Specific CGMP violations included inadequate procedures to prevent microbiological contamination, insufficient investigation of batch failures (e.g., crystallization), and failure to conduct identity tests or validate supplier analyses at Sandoz Canada. At Sandoz Broomfield, deficiencies involved inadequate production/process control procedures (equipment validation), incomplete batch failure investigations, and poor equipment cleaning. Sandoz Wilson also had inadequate production/process control procedures due to unvalidated equipment usage. The FAR violation at Sandoz Canada stemmed from not reporting crystallization complaints and stability failures within three working days.

FDA noted these were often repeat violations, indicating Novartis's failure to implement global and sustainable corrective actions and an ineffective quality system. The company is required to promptly correct all violations, provide a written response within fifteen working days detailing corrective actions and supporting documentation, and schedule a regulatory meeting within five days to discuss plans and corporate involvement. Failure to comply may result in withholding new drug application approvals, refusal of product admission into the U.S., legal action, and impact on federal contracts.