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Medical Devices / Inspections and Audits

FDA Cites AccessClosure Over Complaint Handling

Dec. 13, 2017

The AccessClosure facility in Santa Clara, California received a Form 483 because it did not satisfactorily establish procedures for handling complaints.

After reviewing the firm’s complaint files, inspectors found that the patient, device and event detail information was not adequately collected, and devices were not gathered for examination.

No documentation was found indicating that the firm followed up to obtain missing or additional information or issued a device recall that would have aided in the investigation.

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