483
Minta Medical LimitedMinta Medical Limited – FDA 483, Jul 28, 2022
Record Details
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.
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ID · 1dfd25bb-9031-4221-b60f-eeae204cc53f
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