# FDA WARNING_LETTER - Baxter Healthcare Corporation - January 27, 2023

Source: https://www.keypedia.com/records/warning_letter/baxter-healthcare-corporation/3e82bbf1-a8b1-4f5d-b6c9-799df5b13d62

> FDA WARNING_LETTER for Baxter Healthcare Corporation on January 27, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2023-01-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected Baxter Pharmaceuticals India Pvt. Ltd. from January 19-27, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include:
1.  **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies, specifically regarding endotoxin testing and their 100% automated visual inspection system. Previous citations for similar issues in May 2022 were not adequately addressed, and a retrospective assessment by a third-party consultant was incomplete. The firm lacked assurance that sterile injectable drug batches were free from visible particulates.
2.  **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** White spots, identified as residual product, were found in a bulk solution holding tank documented as clean, exceeding post-cleaning residue limits. The firm's response regarding visual inspection and impact assessment was deemed inadequate.
3.  **Inadequate Production and Process Controls (21 CFR 211.100(a) and (b)):** The visual inspection program for sterile injectable drug products did not assure product quality, particularly regarding particulate matter. The firm's proposed corrective actions for manual visual inspection were insufficient.
4.  **Inappropriate Equipment Design and Maintenance (21 CFR 211.63):** Damaged equipment

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## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Rishikesh Jaiwant](https://www.keypedia.com/people/rishikesh-jaiwant/4ea98e69-8b90-4c61-a27c-4c1d732b027c)

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/738590ab-c241-4de1-aaec-722e154bfc45

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c