FDA 483 - Recipharm Strangnas AB - September 06, 2019

Recipharm Strangnas AB, a drug product manufacturer in Strangnas, Sweden, was inspected by the FDA and received a Form 483 with 10 observations. The inspection revealed significant deficiencies across multiple areas, including inadequate quality control unit procedures, lack of written production controls, issues with equipment calibration and cleaning, and poor facility maintenance regarding pest control. Further concerns involved improper drug product storage, insufficient GMP training, and failures in laboratory controls and computer system security.