FDA Hits Medex Cardio-Pulmonary on Complaints, Control Records, Sterility

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.

The FDA faulted the company on its record-keeping for drug complaints, noting it did not always include the results of investigations. Furthermore, the company did not perform routine inspection and checking of electronic equipment according to a program designed to ensure adequate performance. The air supply for the production area lacked an appropriate air filtration system, and as of June, the firm had not opened a formal CAPA since 2014.

Document control procedures also lacked several required elements, including document numbers, current revisions and document titles. Company records for out-of-specification products did not include the machine technician responsible for the deviation. Investigators also reported that management failed to make sure all employees understood, implemented and maintained the company’s quality policies.