FDA Cites California Drugmaker for Lacking Quality Unit

June 10, 2019

The FDA rapped a California cosmetic drug manufacturer for lacking a dedicated quality control team and other violations.

The agency’s inspection of Ingenue Care’s plant in Norwalk, Calif., between Nov. 16 and Dec. 6 found that the facility also lacked written specifications for its drug products and failed to document testing of active ingredients for identity and strength.

The firm had no written stability testing program and no documentation of stability testing to support a two-year expiration on the label for one product. It also lacked a written testing program for its finished products and employees were not properly maintaining batch production and control records, the Form 483 stated.

In addition, the facility had no written procedures for production and process controls to ensure products had the specified identity, strength, quality and purity.

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