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 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.