FDA 483 - Douglas Pharma US - June 15, 2021

Douglas Pharma US, a contract testing laboratory in Warminster, PA, was cited for significant issues during an FDA inspection. Observations included a lack of appropriate controls for electronic data integrity, allowing data deletion and inadequate data integrity reviews. Additionally, the firm failed to consistently conduct investigations into unexplained discrepancies, improperly categorizing deviations as "planned" to avoid necessary corrective actions.