FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

California Devicemaker Hit for Auditing, Complaint Files

Feb. 5, 2019

The FDA took issue with Evans Manufacturing’s quality audits and complaint handling at its Garden Grove, California facility, during an Oct. 9-11, 2018 inspection.

The facility’s product manager confirmed, when asked by the agency, that the firm did not conduct internal audits in the previous two years and had no written internal audit procedures.

Additionally, the firm lacked complaint handling procedures, and no documentation existed for a complaint to show that it was reviewed and evaluated to assess if an investigation was needed.

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