FDA 483 - Shilpa Medicare Limited - November 30, 2017

Shilpa Medicare Limited received an FDA Form 483 following an inspection conducted from November 10 to November 30, 2017, at its sterile and non-sterile drug manufacturing facility in Polepally, Jadcherla, Mahabubnagar, Telangana, India. The inspection revealed significant deviations from current Good Manufacturing Practices, primarily concerning product quality, stability, and sterility assurance. Key observations included unsupported product labeling for injection hold times and storage, leading to product failures; a lack of scientific justification for various commercial product specifications; and deficiencies in equipment cleaning and maintenance procedures. The firm also failed to thoroughly investigate unexplained discrepancies, such as repetitive product appearance complaints and invalid Out-of-Specification laboratory results. Numerous issues were noted regarding sterility assurance, including inadequate documentation of interventions during production, faulty media fill practices, insufficient microbial monitoring, and unvalidated microbial testing methods. Furthermore, the stability program utilized non-stability-indicating methods, and analytical testing software allowed unjustified changes to data integration. The quality control unit's sampling and testing criteria were deemed inadequate, and visual inspection training kits were incomplete. These observations necessitate comprehensive corrective actions to ensure product quality and regulatory compliance.