FDA Chides Combination Product Firm for Complaint Handling
Menlo Park, California manufacturer of drug-device combination products, Intersect ENT, was hit with a Form 483 over its complaint reporting practices.
During a Feb. 27-March 6 inspection, the FDA noted that employees failed to report timely complaints as required by the firm’s standard operating procedure.
In one instance, an employee was alerted to an adverse event complaint on Dec. 5, 2018, but took nearly two weeks to file a complaint report.
The agency’s investigator also noted that production employees were not given timely training for revised procedures as required by the firm’s standard operating procedures.