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Medical Devices / Inspections and Audits

San Francisco Devicemaker Draws FDA Warning

Sept. 24, 2018

The FDA issued a warning letter to a San Francisco device manufacturing facility for nonconforming process validations and documentation of acceptance activities.

The agency inspected the ITG-Medev facility in June and found that it failed to validate its sterilization process. In its response, the company said it would have a third-party contract laboratory conduct the sterilization validation and provide the FDA with validation results.

The FDA noted the firm had failed to provide the agency with any additional response or corrective action information.

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