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

Source: https://www.globalkeysolutions.net/records/483/femcare-ltd/79a89e94-cdf2-471a-ad77-50a836c6c1d2

> FDA 483 for Femcare, Ltd. on July 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Femcare, Ltd.
- Inspection Date: 2019-07-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/femcare-ltd/a4e09802-8bf6-4579-bc48-ecc63d251b9e

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd