The FDA hit Raleigh devicemaker Allwell Medical with a Form 483 for lack of document control procedures observed in a July 1-2 inspection.
The agency found that Allwell’s complaint handling procedure wasn’t properly maintained. The procedure lacked an authorization signature from customer support personnel. It did not “adequately reflect [its] complaint handling process” and did not include device malfunctions in its medical device reportability evaluation.
The agency also wrote the firm up for its document control procedure, which didn’t require a records of changes made to quality procedures.