Trimed Lands Form 483 For Inadequate Procedures
The FDA issued a Form 483 to Trimed, citing procedural failures, as well as labeling and reporting problems.
In a March 2016 inspection of the medical device manufacturer’s Santa Clarita, California, facility, the inspector noted the firm failed to properly evaluate complaints of possible device failures, and did not submit an MDR report within 30 days of being informed of risks of a malfunction — a repeat observation dating back to a 2012 inspection.
The agency identified several issues with record-keeping. For example, the company failed to keep records of a correction or removal action that was not required to be reported to FDA.
Trimed also lacked adequate procedures for design control, written MDR procedures, product handling, and corrective and preventive actions, according to the Form 483. The company had not established procedures for quality audits and had not validated software used in its quality systems.