DermaPharm A/S – FDA Warning Letter, Sep 19, 2019

On March 10, 2020, the FDA issued a Warning Letter to DermaPharm A/S following an inspection from September 16-19, 2019, at their Farup, Denmark facility. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated. The firm's October 24, 2019, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a)):** DermaPharm A/S failed to test their OTC (b)(4) drug product, labeled for children, for identity and strength of the active ingredient before release. The firm's response was inadequate as it did not address previously released batches or testing of reserve samples. 2. **Failure to verify component identity and validate supplier analyses (21 CFR 211.84(d)(1) and (2)):** The firm did not perform incoming identity testing for the raw material "(b)(4)" (containing (b)(4), the active ingredient) and relied on supplier Certificates of Analysis without validating their reliability. 3. **Failure to establish adequate written procedures for process control and validation (21 CFR 211