FDA Hits Spectra Therapy for Lack of Written Procedures

The FDA cited Spectra Therapy for deficiencies in design control, medical device reporting and CAPA procedures.

The agency issued a Form 483 following a November/December inspection of the device manufacturer’s Troy, Michigan facility. According to investigators, the company designed and developed its Spectra A-100 Impulse Laser Device without design control procedures.

The agency also faulted the facility on its written MDR procedures. The facility lacked written procedures to ensure timely identification and evaluation of events that potentially require MDRs, or a standardized review process for determining which events are reportable, or for timely transmission of MDRs.