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Medical Devices / Inspections and Audits

FDA Cites California Devicemaker for Complaint Handling

Sept. 11, 2019
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The FDA hit Wildomar-based device manufacturer AIDI Biomedical with a Form 483 for failing to investigate certain complaints.

An agency inspection found that multiple dental implants were returned by dental practices and offices. The agency reviewed eleven complaint records and saw that although infections were noted in an unspecified amount of them, AIDI did not look into the issue further to determine reportability.

In addition, an unspecified number of complaints reported the implants filed to connect with living bone in the patient, which the company also neglected to further investigate.

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