Mediagnost GmbH – FDA Warning Letter, Jan 11, 2012

On May 8, 2012, the FDA issued a Warning Letter to Mediagnost GmbH following a January 9-11, 2012 inspection in Reutlingen, Germany, which found their Human Growth Hormone diagnostic kits to be adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to validate processes:** The (b)(4) process for human growth hormone production was not validated (21 CFR 820.75(a)). The firm's response was inadequate, lacking a systemic retrospective review plan for process/equipment validations. 2. **Inadequate production process control:** Production processes were not adequately developed, conducted, controlled, or monitored to ensure device conformity (21 CFR 820.70(a)). The firm's response was insufficient, not indicating a review of other quality control results or a plan for employee training on revised procedures. 3. **Inadequate acceptance activities procedures:** Device History Records (DHRs) were approved with out-of-specification test results, and acceptance criteria were not adequately established (21 CFR 820.80). The firm's response was inadequate, as it did not provide a rationale for limiting retrospective product evaluation to two years. 4. **In