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Medical Devices / Inspections and Audits

FDA Cites Minnesota Devicemaker for Missing Complaint Procedures

May 31, 2019

Failure to establish a mechanism for properly documenting complaints earned a Shakopee, Minnesota device manufacturer a Form 483 from the FDA.

Exercore, which manufactures a eustachian tube exerciser for unclogging blacked ears, did not have a procedure in place for documenting complaint information, the agency found during its Nov. 19-Dec. 18, 2018 inspection.

The firm neglected to develop a procedure for collecting information relevant to complaints, including the device name, date of complaint, device identification, control or lot numbers, any corrective action taken and any reply to the complainant, among other items, the agency said.

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