Pfizer Healthcare India Private Limited – FDA Warning Letter, Sep 6, 2019

The FDA issued a Warning Letter to Pfizer Healthcare India Private Limited following an inspection from August 29 to September 6, 2019, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: - **Inadequate Investigations:** Failure to thoroughly investigate unexplained discrepancies or failures, specifically regarding sterility testing and environmental monitoring. For instance, a sterility failure in February 2019 for an injectable batch was attributed to a faulty (b)(4) and lack of robust integrity testing, but the same (b)(4) was used for numerous subsequent batches before replacement. - **Environmental Monitoring Program Deficiencies:** Inadequate investigation of serious deficiencies in microbiology laboratory conditions, including excessive negative control plate contamination, high contamination levels in sterility test (b)(4) environmental monitoring samples, and disregarded environmental monitoring data due to delayed plate readings. Microbial results were invalidated without adequate scientific justification due to extended incubation times, impacting approximately (b)(4) batches. - **Data Integrity Issues:** The quality system did not adequately ensure the accuracy and integrity of data supporting drug safety, effectiveness, and quality.

Required corrective actions include comprehensive assessments and remediation plans for: - Overall deviation investigation system, including competencies, root cause evaluation, and CAPA effectiveness. - CAPA program, focusing on root cause analysis, effectiveness, and management support. - Documentation systems to ensure attributable, legible, complete