# FDA 483 - Rhone-Poulenc Rorer - April 27, 2026

Source: https://www.keypedia.com/records/483/rhone-poulenc-rorer/178575fc-5b7e-470f-96b4-c4325eceebb9

> FDA 483 for Rhone-Poulenc Rorer on April 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rhone-Poulenc Rorer
- Inspection Date: 2026-04-27
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Rhone-Poulenc Rorer in Dagenham, Essex U.K. revealed significant deficiencies in quality system controls related to the manufacturing of FERRLECIT INJECTION. Observations included unfinalized standard operating procedures, inadequate monitoring, and incomplete validation activities. These issues indicate a lack of robust control over critical manufacturing processes.

## Related Officers

- [Fred C. Fricke](https://www.keypedia.com/people/fred-c-fricke/3c3050f4-2659-445d-8306-a92b8e3297d0)
- [Robert Shaponnick](https://www.keypedia.com/people/robert-shaponnick/4c4fd87b-dcfa-43d1-a7d3-dbc73a0595d7)

Company: https://www.keypedia.com/companies/rhone-poulenc-rorer/4de4a7dc-1bdf-495a-a3b1-ddc316c0801f

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4