The FDA issued Greenwood Village, Colorado-based company LED Technologies a Form 483, after observing poor complaint handling, an inadequate design history file and a failure to conduct trend analyses.
One of the firm’s corrective and preventive action procedures required the firm to conduct trend analyses in order to evaluate reported complaints, non-conformities, quality records, audit reports, documentation and production processes. The agency discovered that the firm had only conducted the analyses as required for reported complaints.
The firm also did not use appropriate statistical methodology when performing a trend analysis for reported complaints. Specifically, it did not provide a mechanism for identifying existing and potential causes of non-conforming product or other quality problems, the agency said.
The design history file for the Spectralite Class II medical device was inadequate for numerous reasons, the agency said. For example, no design validation was performed. In addition, the documentation of design reviews did not include all required participants, including a person who had no responsibilities for the design stage being reviewed. There was also no objective evidence that design transfer had occurred.