# FDA 483 - Baxter Pharmaceuticals India Pvt Ltd - June 27, 2025

Source: https://www.keypedia.com/records/483/baxter-pharmaceuticals-india-pvt-ltd/68b3ba63-2f11-4912-8a22-a1dfa76b2843

> FDA 483 for Baxter Pharmaceuticals India Pvt Ltd on June 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Pharmaceuticals India Pvt Ltd
- Inspection Date: 2025-06-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Baxter Pharmaceuticals India Pvt Ltd. in Ahmedabad, India, a sterile drug product manufacturer, received a Form 483 with three observations. The inspection revealed significant deficiencies including a lack of written procedures for production and process controls, inadequate investigations into Out-of-Specification results and recurring issues like pH instability and particle contamination, and a failure to timely submit Field Alert Reports. These findings indicate systemic quality control and reporting failures.

## Related Documents

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## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Investigator](https://www.keypedia.com/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8