The FDA cited an Illinois device manufacturer over its investigation of discrepancies, control records and complaint handling.
The agency issued a Form 483 to Medex Cardio-Pulmonary after a June/July inspection found the firm’s quality unit failed to investigate out-of-specification test results in several cases. The facility’s batch production and control records were incomplete, lacking full documentation of aseptic filling operations to ensure they were performed according to procedure, the agency said.
The facility’s aseptic processing areas were also inadequate, with investigators noting an employee performing sanitization procedures for the fill system enclosure wearing non-sterile gloves. The company also failed to perform dynamic smoke studies to validate the sterilization process.