Inspectors Find Validation and CAPA Problems at LAR NE
The FDA faulted LAR NE for its validation, corrective and preventive action, and other procedures.
An inspection of the firm’s Port Richey, Fla., facility in September 2016 found no validation records for the cleaning and coating process for orthodontic brackets.
In a Form 483, the agency said the company lacked proper CAPA procedures. Specifically, it did not fully define and implement a process for analyzing quality data. The CAPA procedures called for an analysis of quality data sources to identify existing and potential causes of nonconforming products, but the firm lacked records to show this was done.