FDA WARNING_LETTER - Fischer ANalysen Instrumente GmbH - November 04, 2022

On February 3, 2023, the FDA issued a Warning Letter to Dr. Martin Schaich, Managing Director of a firm in Leipzig, Germany, following an inspection from November 1-4, 2022. The inspection revealed that the firm's PyloPlus UBT System 13/12CO2 breathing gas analyzer devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **Software Validation (21 CFR 820.30(g)):** Inadequate documentation for PyloPlus device software revision 1.49 validation, lacking software revision plans, input specifications, approved test plans, and complete test results. The firm's response was inadequate, as it did not include a systematic retrospective review of previous software revisions. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** CAPA procedures lacked requirements for identifying sources and