FDA 483 - Minta Medical Limited - July 28, 2022

Minta Medical Limited, a medical device manufacturer in Prescot, United Kingdom, received an FDA Form 483 citing significant quality system deficiencies. Observations included inadequate process validation for their Disposable R-F Thermocouple Electrode, specifically concerning sterility testing and requalification intervals. The firm also lacked established procedures for statistical techniques and failed to maintain a device master record for the product.