The FDA hit Akorn with a lengthy Form 483 with 13 observations for failing to properly safeguard against microbiological contamination and to monitor conditions in aseptic processing areas following April/May inspections of its Decatur, Illinois, facility.
The agency faulted the facility’s control procedures for lacking a baseline for what constitutes “foreign matter” during the visual inspection process for finished sterile injectable drug products.
Inspectors found the facility also failed to follow its SOPs on cleaning and sanitizing of manufacturing areas on several occasions after observing operators in aseptic areas placing fallen vials back onto the line.
The company also failed to conduct adequate investigations of unexplained discrepancies and failures of batches to meet specifications.
In addition, reserve samples from representative lots or batches were not visually examined for evidence of deterioration at least once a year, the agency said.