FDA 483 - Diva International Inc. - March 12, 2015

Diva International Inc., a medical device manufacturer in Kitchener, Canada, received an FDA Form 483 citing multiple quality system deficiencies. The inspection revealed inadequate procedures and records for complaint handling, insufficient documentation of corrective and preventive actions, and a complete lack of written procedures for Medical Device Reporting. These observations highlight significant areas for improvement in the firm's regulatory compliance.