# FDA WARNING_LETTER - Baxter Healthcare Corporation - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/baxter-healthcare-corporation/38c366e8-7c89-43c3-9ec2-0991b551bef7

> FDA WARNING_LETTER for Baxter Healthcare Corporation on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Baxter Healthcare Corporation
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Baxter Healthcare Corporation's Irvine, California facility (December 2012 - June 2013) found its elastomeric infusion pumps and specialty medical devices adulterated, non-compliant with the Quality System regulation (21 CFR Part 820). This indicated systemic manufacturing and quality control deficiencies. Key violations included inadequate procedures for corrective and preventive actions (21 CFR § 820.100(a)), design output (21 CFR § 820.30(d)), and nonconforming product control (21 CFR § 820.90(a)). The firm also failed to record changes (21 CFR § 820.40(b)), establish acceptance activity procedures (21 CFR § 820.80(a)), and properly validate processes (21 CFR § 820.75(e)) and software (21 CFR § 820.70(i)). Supplier requirements were not established (21 CFR § 820.50(a)), document control was deficient (21 CFR § 820.40), equipment calibration was inadequate (21 CFR § 820.72(a)), and device history records did not conform to master records (21 CFR § 820.184). Baxter's responses were inadequate, often promising re-engineered systems without specific details. The FDA requires prompt, comprehensive corrective action, with a detailed written response within fifteen business days outlining steps, prevention plans, and a timetable. Failure to comply could lead to severe regulatory actions, including seizure, injunctions, civil penalties, and impact on federal contracts and device approvals.

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## Related Officers

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/3a2bb12d-f7e5-4c09-9678-b4bec58553a9

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b