# FDA 483 - Regenerative Processing Plant LLC - June 23, 2023

Source: https://www.keypedia.com/records/483/regenerative-processing-plant-llc/e6594f04-1013-4cac-bc35-443986fd8200

> FDA 483 for Regenerative Processing Plant LLC on June 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regenerative Processing Plant LLC
- Inspection Date: 2023-06-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Regenerative Processing Plant LLC, an OTC drug manufacturer in Tampa, FL, was inspected by the FDA and received a Form 483 with four observations. The observations primarily concern inadequate control over drug product storage conditions, lack of equipment monitoring records, insufficient sanitation procedures, and incomplete distribution records. These issues indicate a need for improved adherence to Good Manufacturing Practices to ensure product quality and purity.

## Related Officers

- [investigator](https://www.keypedia.com/people/samantha-j-pinizzotto/296e8763-39e9-4b6d-9b89-661322d5a53c)
- [Annette Melendez](https://www.keypedia.com/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)
- [Dan E Reyes](https://www.keypedia.com/people/dan-e-reyes/d81431e5-855d-4709-871e-a5f59fef44c8)

Company: https://www.keypedia.com/companies/regenerative-processing-plant-llc/492bd1c0-c445-4953-ac83-8a1d9f3944df

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