Marel Corporation – FDA Warning Letter, Jun 24, 2014

On August 11, 2014, the FDA issued a Warning Letter to Marel Corporation following an inspection from May 30 to June 24, 2014. The inspection determined Marel Corporation is a repackager/relabeler of sterile towel/drapes, classified as devices under section 201(h) of the Act. The devices were found to be adulterated under section 501(h) of the Act, as manufacturing, packing, storage, or installation methods did not conform to the Quality System Regulation (21 CFR Part 820).

Violations included: 1. Failure to validate processes (21 CFR 820.75(a)): No validation documentation for ETO sterilization's effect on packaging, or post-sterilization package integrity testing. Pre-sterilization packaging validation was inadequate, lacking specific packaging/machinery details and material identification. The "Packaging Machine Validation" procedure was incomplete, missing a page from the test method and acceptance criteria for seals. 2. Failure to monitor and control process parameters for validated processes (21 CFR 820.75(b)): No requalification assessments for the ETO sterilization process since 2010, despite a requirement for (b)(4) assessments. 3. Failure to control and monitor production processes (21 CFR 820.70(