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Home » FDA Cites Novabay for Design Control Procedures
FDA Cites Novabay for Design Control Procedures
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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.
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