# CosmoFrance, Inc. – FDA 483, Sep 16, 2021

Source: https://www.keypedia.com/records/483/cosmofrance-inc/06475a21-271b-4def-9376-d4ef6a9e43c2

> FDA 483 for CosmoFrance, Inc. on September 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CosmoFrance, Inc.
- Inspection Date: 2021-09-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of CosmoFrance, Inc., a relabeler/repackager of medical devices in Miami, FL, revealed significant deficiencies in their quality management system. Observations included inadequate control over document changes, failure to properly document corrective and preventive actions, and a lack of documentation for incoming product acceptance. These issues indicate a need for comprehensive improvements in their operational procedures and record-keeping practices.

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.keypedia.com/companies/cosmofrance-inc/7d90be73-0aee-4bbc-b296-8d1ba63e8ba2

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6