FDA 483 - Prince Medical S.A.S. - December 08, 2022

An FDA inspection of Prince Medical S.A.S., a medical device manufacturer in Ercuis, France, revealed significant deficiencies in their quality system. Observations included inadequate complaint handling procedures, a repeat finding from a previous inspection, and failures in documenting design verification results. Additionally, the firm lacked established requirements for contractors and consultants, and procedures for corrective and preventive actions were not properly implemented.