FDA 483 - Baxter Pharmaceuticals India Pvt Ltd - August 04, 2017

The FDA Form 483 inspection revealed significant deficiencies across multiple aspects of the facility's operations and quality systems.

**Facility and Operations:** * **Environmental Control:** Severe structural issues were observed in the personnel corridor leading to controlled manufacturing areas, including water dripping/seeping from the ceiling in 27-28 areas, a 15.24cm x 12.7cm wall breakage, and unsealed ceiling panels allowing air ingress from the plenum into the personnel corridor and post-sterilization area. * **Aseptic Processing:** Aseptic technique was deficient. Airflow pattern evaluations (smoke studies) lacked proper simulation of personnel interventions, RABs access, and failed to adequately visualize airflow due to personnel obstruction. A manual intervention on the conveyor exposed the ISO-5 interior to an ISO-7 environment without physical separation. * **Water System:** The sampling for water for injection (WFI) did not include production equipment hoses/pipes, and the sampling method did not accurately reflect routine conveyance. Microbiological monitoring data for point-of-use sites and hose lengths was absent.

**Quality System and Manufacturing Issues:** * **Documentation and Data Integrity:** Electronic records did not support environmental monitoring authenticity. Controlled documents were not appropriately controlled. Media fill records were false. * **Complaint Handling:** Complaint follow-up was deficient. * **Out-of-Specification (OOS) Management:**