FDAnews Device Daily Bulletin

FDA Cites Mb Industria Cirurgica on CAPA, Training

July 26, 2017

Cirurgica landed a Form 483 from the FDA for inadequate process validation, CAPA procedures, environmental conditions and training.

The agency issued the form following a March inspection of its facility in Paulista, Brazil. Investigators found numerous manufacturing processes for the firm’s Omiderm device had not been verified and also fell short on several procedures to control environmental conditions.

Further investigation found the firm had no procedures to ensure timely and effective assessment of events that might qualify for medical device reporting requirements. Investigators also hit the company on its CAPA procedures, finding they did not require analysis of quality data to identify existing and potential or recurring issues. It also lacked requirements to ensure all quality problems were communicated to those responsible for quality.

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