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The company failed to review and investigate MDR reportable complaints and incorrectly assigned risk index levels to complaints, which are assigned by the firm’s complaint handling unit. Read More
Investigators also found that the company did not adequately validate a heat sealer to simulate equipment operating conditions during the packaging process. Read More
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. Read More