FDA 483 - Rottendorf Pharma Gmbh

An FDA inspection of Rottendorf Pharma Gmbh, a drug product manufacturer in Ennigerloh, Germany, identified deficiencies in their instrument calibration procedures. Specifically, the firm failed to adequately evaluate the linearity and accuracy of a mass balance used for in-process testing of core tablets at critical lower weight ranges. This indicates a potential gap in ensuring the quality and consistency of their drug products.