FDA 483 - DermaPharm A/S - September 19, 2019

DermaPharm A/S, an OTC drug product manufacturer in Farup, Denmark, was cited for three observations during an FDA inspection. The observations primarily concern deficiencies in laboratory controls, including inadequate testing of finished drug products for potency and microbial contamination, a lack of established specifications for drug products and raw materials, and the absence of written procedures for investigating unexpected laboratory results.