Femcare, Ltd.July 25, 2019

FDA 483 - Femcare, Ltd. - July 25, 2019

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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.

Company: Femcare, Ltd.
Inspection Date: July 25, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Matthew M. Vernon (investigator)

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ID · 79a89e94-cdf2-471a-ad77-50a836c6c1d2