FDA WARNING_LETTER - Praxair Inc. - August 08, 2014

On July 29, 2014, an FDA inspection of Praxair Inc. in Tonawanda, NY, identified Quality System and Medical Device Reporting (MDR) violations for their medical gas flow regulators. The devices were deemed adulterated under 21 U.S.C. § 351(h) for non-conformity with 21 CFR Part 820 (Quality System regulation) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 CFR Part 803 (MDR).

Key violations included: 1. Failure to establish procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198), with specific issues in complaint file content and investigation. 2. Failure to establish corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), lacking analysis and handling of quality data, and verification/validation of CAPAs. 3. Failure to establish procedures ensuring purchased products and services conform to requirements (21 CFR 820.50), specifically regarding supplier agreements and review/approval of supplier changes. 4. Failure to submit MDRs within 30 days for device malfunctions likely to cause death or serious injury (21 CFR 803.50(a