# FDA 483 - Baxter Pharmaceuticals India Pvt Ltd - May 17, 2022

Source: https://www.keypedia.com/records/483/baxter-pharmaceuticals-india-pvt-ltd/fe9fbabc-09a9-4ef2-a20a-d002a0b147cc

> FDA 483 for Baxter Pharmaceuticals India Pvt Ltd on May 17, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Baxter Pharmaceuticals India Pvt Ltd
- Inspection Date: 2022-05-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Baxter Pharmaceuticals India Pvt Ltd in Ahmedabad, India, from May 9-17, 2022, revealed severe and recurring deficiencies in its sterile manufacturing operations. The firm demonstrated inadequate quality unit oversight, insufficient investigations into cGMP discrepancies and OOS results, and failures in environmental monitoring and aseptic practices. Many of the issues cited were previously identified in past FDA inspections, including a 2018 Warning Letter, indicating a systemic failure to implement effective corrective actions.

## Related Documents

- [483 - 2016-08-26](https://www.keypedia.com/records/483/baxter-pharmaceuticals-india-pvt-ltd/8d6b285d-5ce8-402f-b886-4fec22c31f44)
- [483 - 2017-08-04](https://www.keypedia.com/records/483/baxter-pharmaceuticals-india-pvt-ltd/39ff32de-a58e-445e-8df1-f22283913a75)
- [483 - 2023-01-27](https://www.keypedia.com/records/483/baxter-pharmaceuticals-india-pvt-ltd/ef796f81-93f2-4622-a308-a6917253f117)
- [483 - 2023-01-27](https://www.keypedia.com/records/483/baxter-pharmaceuticals-india-pvt-ltd/f91c47f3-62e9-40f3-baf3-9f707eafbdfd)
- [483 - 2023-01-27](https://www.keypedia.com/records/483/baxter-pharmaceuticals-india-pvt-ltd/25cb0e8f-58f3-4a60-a7e3-bac9f78f52c8)

## Related Officers

- [Drug Cadre](https://www.keypedia.com/people/drug-cadre/3c9d24f9-082f-4d39-8796-e32693cf6d4b)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1