FDA WARNING_LETTER - Midmark Corporation - September 12, 2011

On December 28, 2011, the FDA issued a Warning Letter to Midmark Corporation following an inspection from August 23 to September 12, 2011, which found their steam sterilizers to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish adequate CAPA procedures (21 CFR 820.100(a))**: Inadequate analysis of quality data, exclusion of non-conformances and post-warranty complaints from analysis, lack of statistical methodology, and insufficient effectiveness checks for CAPA activities. Midmark's response was deemed inadequate, citing unapproved procedures, lack of procedural direction for data review, and absence of statistical thresholds. 2. **Failure to control nonconforming product (21 CFR 820.90(a))**: Procedure 5.5 did not describe actions for nonconforming finished devices or rework documentation in Device History Records (DHRs). While the revised procedure for finished devices and rework was adequate, implementation issues persisted, as DHRs lacked nonconformances from ASME inspector's notebooks, and "Offline Sheets" for nonconformances were not addressed. 3. **Failure to control production processes (21 CFR 8