California Firm Written Up for Procedural Violations

The FDA issued a Form 483 to Asuza, California device company Westwood Laboratories for failing to require the logging and investigation of nonconformances.

The firm’s procedure for handling nonconforming materials and products did not require that they be documented and evaluated, and the company had no log of finished and raw product nonconformances, the agency found.

The firm also had no system in place that checked the effectiveness of CAPAs, and no corrective action was taken for out of range temperatures in storage areas.