FDA Cites Texas Firm for Missing Procedures

The FDA hit devicemaker Libra Industries of Richardson, Texas with a Form 483 because it lacked a procedure for handling complaints.

An agency inspection of the facility revealed that it had no procedure to manage oral complaints, to assess if the complaints should be submitted to the FDA as medical device reports and to determine if an investigation was needed.

The firm’s  procedure for controlling nonconforming material also failed to address documenting and evaluating nonconformance investigations.