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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
The company’s website contained a note informing readers of the purchasing restrictions, but it sold and distributed them with no such restrictions. Read More
The agency also found device master records did not address elements such as device/component specifications, production methods and procedures, or quality assurance procedures. Read More
The company’s receiving inspection report for at least one lot did not have the required signatures of personnel responsible for the inspections. Read More
The FDA issued 483s to six device facilities for a variety of deficiencies including design control procedures, data integrity, CAPAs and complaint handling. Read More