FDA 483 - Aspen Oss B.V. - September 09, 2019

Aspen Oss B.V., a drug manufacturer in Oss, Noord-Brabant NL, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included a lack of validated control procedures leading to out-of-specification drug product test results and non-representative sampling practices. The firm also failed to adequately investigate unexplained discrepancies and OOS microbial counts, and did not document the examination and reconciliation of packaging and labeling materials in batch records.