Stericon Pharma Pvt. Ltd. – FDA Warning Letter, Mar 17, 2010

The FDA issued a Warning Letter to Stericon Pharma Pvt. Ltd. following a March 2010 inspection of their Bangalore, India drug manufacturing facility, identifying significant Current Good Manufacturing Practice (CGMP) violations. These violations render their drug products adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Aseptic Processing Contamination Prevention (21 C.F.R. § 211.42(c))**: * Deficient environmental monitoring: failure to conduct active/non-viable air sampling during filling, and inadequate identification of environmental isolates. * Lack of documented in-situ air pattern analysis (smoke studies) in critical areas to demonstrate unidirectional airflow under dynamic conditions. * Insufficient monitoring of differential pressures in aseptic processing areas, including continuous monitoring, frequent recording, and investigation of alarms/deviations.

2. **Personnel Qualification (21 C.F.R. § 211.25(a))**: * No procedures for qualifying operators in aseptic processing areas, including ongoing evaluation of aseptic techniques and gowning qualification.

Additional deficiencies noted include incomplete documentation for autoclave cycle validation, discrepancies between equipment qualification and batch records (e.g., mixing speeds), and failure to monitor storage conditions for raw materials, components, and finished drug products.

Stericon Pharma must