Trilliant Cited for Failure to Establish Adequate Design Validation

The FDA slapped Houston, Texas-based Trilliant Surgical with a five-item FDA-483 that highlighted numerous lapses in corrective and preventive actions following an inspection covering Jan. 16, 2015 to Feb. 12, 2015.

FDA investigator Ellen Tave cited the firm for not adequately establishing CAPA procedures for numerous nonconforming products that were broken during surgery and were left implanted in patients. The investigator noted that the firm issued medical device advisory notices but did not document its justification for not reporting those actions to the FDA. The investigator noted that this was a repeat observation.

In addition, the Feb. 12 483 notes that procedures for design validation were not adequately addressed, which was also a repeat observation from a 2010 inspection for which the firm received a warning letter.

That warning letter listed numerous quality system violations including failure to investigate the cause of nonconformities, failure to verify CAPA, and failure to maintain adequate purchasing records and complaint procedures. On Aug. 17, 2012, the FDA issued a closeout letter that the deviations had been addressed.

The investigator also cited the firm for not establishing procedures for design changes.

Tave listed at least seven examples of the firm not reviewing and evaluating complaints. In one example, a drill bit fractured a patient’s foot during surgery, but the complaint report did not document how the company determined the lot number, nor did it complete risk assessment reports.

Finally, the firm also did not adequately document labeling for each finished product, lot or batch in the device history record.

Trilliant did not respond to a request for comment by deadline.

Inadequate validation was cited more than 600 times in 483s issued to device and drug manufacturers in 2013. Isn’t it time to get it right? Understanding Validation provides an introduction, overview and three case studies designed for your employees at both managerial and operator levels.