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

Source: https://www.keypedia.com/records/483/baxter-pharmaceuticals-india-pvt-ltd/39ff32de-a58e-445e-8df1-f22283913a75

> FDA 483 for Baxter Pharmaceuticals India Pvt Ltd on August 04, 2017. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Pharmaceuticals India Pvt Ltd
- Inspection Date: 2017-08-04
- Office Name: Office of Compliance
- Summary: 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:**

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Company: https://www.keypedia.com/companies/baxter-pharmaceuticals-india-pvt-ltd/dc51d849-2ff2-4ad0-bb54-cb013fd2e24d

Office: https://www.keypedia.com/offices/office-of-compliance/d6cb6d9a-dc29-4722-9ba6-783ba341d981