FDA Flags Seiler for Undocumented Changes, Lack of MDR Procedures

The FDA cited a St. Louis device manufacturer over CAPA procedures, failure to report all corrections and problems with complaint handling.

The agency conducted an inspection at Seiler Instrument and Manufacturing’s St. Louis facility last October and issued a Form 483. According to investigators, the facility did not analyze service records or complaints to determine the cause of quality problems and non-conformances.

The investigator also found that the company responded to a customer complaint about its Alpha Air 6 ENT operating microscope unit toppling over by updating its medical presentation to warn of the potential hazard. It also updated the product’s user’s manual to note that users must use the handles mounted on the device when transporting it. But the company failed to notify the FDA that it was taking either action.

Seiler also lacked adequate procedures for quality audits. According to the 483, the company told the FDA that it did not review its quality system to verify compliance with regulations. The facility did not require documentation of all complaints, review of them to determine the necessity of an investigation, or conduct an investigation to identify whether an MDR-reportable event had taken place.