FDA Calls Out Florida Contract Manufacturer for Complaint Handling
The FDA took Sunrise, Florida firm Inneuroco to task over complaint handling violations, issuing the firm a Form 483 for the deficiencies.
An investigation by the agency found that the company didn’t follow its procedure for customer complaints. Specifically, the agency discovered 11 complaints that didn’t include defect/failure trending or root cause analysis.
The firm’s complaint procedure was also deficient in that it had no requirements for investigating complaints without a lot number.