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Medical Devices / Inspections and Audits

FDA Cites Novabay for Design Control Procedures

Feb. 12, 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.

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