www.fdanews.com/articles/190193-fda-cites-novabay-for-design-control-procedures
FDA Cites Novabay for Design Control Procedures
February 11, 2019
Novabay Pharmaceuticals, an Emeryville, California drug and device manufacturer, was hit with a Form 483 for faulty design control procedures.
The firm’s design control procedure described design validation as “optional,” and the company was unable to provide a documented design validation.
The procedure also said that reviews for transition and major designs are recorded on the design review report form — but the firm had no proof of a design review conducted before the product’s release to market.