FDA 483 - Baxter Pharmaceuticals India Pvt Ltd - August 26, 2016

This FDA Form 483 details multiple violations observed during an inspection. The facility failed to follow written production and process control procedures. Specifically, an analyst conducting endotoxin testing on Injectable Lot # and Lot # tilted test tubes less than 90 degrees, insufficient for consistent gel clot formation observation per SOP # QCD/018. Laboratory media for sterility testing was not labeled with lot number, name, or date made/expiring, contrary to SOP # QCD/014. Prepared plates in the sterile testing area had easily detached labels, compromising identity and traceability. Media plates from Environmental Monitoring/Sampling and personnel testing were wiped free of identification labels before being read by the Auto Colony Counter, and the digital photo taken by the counter did not include plate identification, violating SOP # QAD/037.

Acceptance criteria for quality control unit sampling and testing were inadequate, as samples for BET testing were not collected in sufficient quantity to be representative of the final batch, per SOP # QAD/032. An apparatus used during sterility testing was not qualified for that purpose.

Procedures to prevent microbiological contamination of sterile drug products were not established, written, or followed. The number of cleaning and sterilization cycles for sterile garments and goggles used for clean room entry (SOP # PRD/004) were not validated, relying on supplier recommendations or visual inspection. Disinfectant/sporicidal contact times were not specified in SOP # PRD/