# FDA 483 - RAPHA Health Network International, Inc. - December 16, 2022

Source: https://www.globalkeysolutions.net/records/483/rapha-health-network-international-inc/07c7d645-78f9-44c8-b4b9-1bcb7ae23f08

> FDA 483 for RAPHA Health Network International, Inc. on December 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RAPHA Health Network International, Inc.
- Inspection Date: 2022-12-16
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of BAPHA Health Network International, Inc., an OTC drug repackager/relabeler in Doral, FL, revealed significant deficiencies in quality control, supplier qualification, deviation management, and batch record documentation. The firm failed to adequately test incoming components, qualify suppliers, investigate deviations, and maintain complete batch production records. These issues indicate a lack of robust quality systems for drug product manufacturing and control.

## Related Documents

- [483 - 2022-09-09](https://www.globalkeysolutions.net/records/483/rapha-health-network-international-inc/36b1d6e6-f1cd-41c8-a05c-17f1fd713282)

## Related Officers

- [Dorothy P. Kramer](https://www.globalkeysolutions.net/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/rapha-health-network-international-inc/9003bbc8-800a-4a19-b377-4d66e37b827d

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