# FDA 483 - RAPHA Health Network International, Inc. - September 09, 2022

Source: https://www.keypedia.com/records/483/rapha-health-network-international-inc/36b1d6e6-f1cd-41c8-a05c-17f1fd713282

> FDA 483 for RAPHA Health Network International, Inc. on September 09, 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: 2022-09-09
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: RAPHA Health Network International, Inc. in Doral, FL, a dietary supplement manufacturer, was inspected by the FDA from September 1-9, 2022. The inspection revealed significant deficiencies in their quality control, production, and laboratory operations, indicating a lack of adherence to good manufacturing practices for dietary supplements. Key issues included inadequate batch production records, failure to establish and follow specifications, and uncalibrated laboratory equipment.

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## Related Officers

- [Benita C. Okeke](https://www.keypedia.com/people/benita-c-okeke/1c62b9fb-4cc6-4d6b-966c-98b471d850e4)
- [Ivis L. Negron Torres](https://www.keypedia.com/people/ivis-l-negron-torres/eb77f360-bb0b-4a13-a0da-b89c36ccaca9)

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

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