FDA 483 - Zaklady Farmaceutyczne Polpharma S.A. - May 25, 2018

An FDA inspection of Zaklady Farmaceutyczne Polpharma S.A. in Starogard Gdanski, Poland, revealed significant deficiencies in quality control and adherence to written procedures. The firm failed to follow its stability sample handling SOP, resulting in numerous deviations and delayed analyses. Additionally, a high number of out-of-specification results were attributed to analyst error, indicating inadequate employee training.