483
Femcare, Ltd.Femcare, Ltd. – FDA 483, Jul 25, 2019
Record Details
Fencare, Ltd., a medical device manufacturer in Romsey, Hampshire, United Kingdom, was cited for inadequate process validation during an FDA inspection. The firm's process validation procedures did not include requirements for major equipment validation. This indicates a significant concern regarding the firm's quality system for ensuring product quality and safety.
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ID · 79a89e94-cdf2-471a-ad77-50a836c6c1d2
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