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The FDA cited Arcamed for deficiencies in its CAPA procedures and issues with its quality audit and employee training procedures after a February/March inspection of the company’s Indianapolis facility. Read More
The FDA slapped Gendron with a Form 483 for shoddy complaint handling and deficient MDR procedures, as well as issues with its internal quality auditing. Read More
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