The US Food and Drug Administration (FDA) on Tuesday released a Form 483 (which can be the precursor to a warning letter) with six observations to one of two Akorn Pharmaceuticals’ Decatur, Illinois-based sterile drug manufacturing facilities.
The observations were uncovered during a 10-day inspection in June and include quality control issues, unrecorded or unjustified deviations from written production and process control procedures, quality control responsibilities and procedures that are not followed, and the company’s failure to extend investigations into batch failures to other drug products that may have been associated with such a failure.
