# FDA 483 - Distributor RFR, LLC. - June 14, 2022

Source: https://www.keypedia.com/records/483/distributor-rfr-llc/3d8339bc-134e-4221-97e5-39ee07944cc9

> FDA 483 for Distributor RFR, LLC. on June 14, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Distributor RFR, LLC.
- Inspection Date: 2022-06-14
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Distributor RFR, LLC. in Doral, FL, a dietary supplement distributor, revealed significant deficiencies in their quality control system. The firm failed to ensure quality control over contracted manufacturing, packaging, and labeling operations, and lacked essential written procedures for product specifications, holding, distribution, complaint handling, and returned products. These issues indicate a systemic failure to comply with regulatory requirements for dietary supplement distribution.

## Related Officers

- [Benita C. Okeke](https://www.keypedia.com/people/benita-c-okeke/1c62b9fb-4cc6-4d6b-966c-98b471d850e4)
- [Angela F. Orozco](https://www.keypedia.com/people/angela-f-orozco/5d5e2e4b-680c-4ff2-9d74-ac9cf3fb4fe6)

Company: https://www.keypedia.com/companies/distributor-rfr-llc/724dcbfd-6e42-4ab5-a144-94ecb139008e

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