FDA 483 - Prince Medical S.A.S. - December 08, 2022
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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.
ID · 59b5f880-ead2-446d-b5de-9206b69f5f83