FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Cincinnati Device Developer Hit for Complaint Handling, CAPA Issues

June 12, 2018

The FDA handed MHC Medical Products a Form 483 after its January inspection revealed multiple deficiencies at its Cincinnati, Ohio facility, including poor complaint handling and management, CAPA issues and procedural shortcomings.

The agency found that the firm did not promptly look into complaints that were MDR reportable. Complaints involving needles breaking off into customers’ stomachs and another complaint regarding a faulty glucose meter were not reported as MDRs and did not have a documented review or evaluation for reportability.

In addition, the firm did not investigate other, less severe complaints, such as ones involving a needle not ejecting liquid, ripped syringe bags and missing needle tops, and the company’s complaint standard operating procedures did not define the firm’s defect codes.

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