# FDA 483 - Rhone- Poulenc Rorer - January 18, 2026

Source: https://www.globalkeysolutions.net/records/483/rhone-poulenc-rorer/858b026b-1f9d-4fc8-bbb3-be285953c900

> FDA 483 for Rhone- Poulenc Rorer on January 18, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rhone- Poulenc Rorer
- Inspection Date: 2026-01-18
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Rhone-Poulenc Rorer in Maisons-Alfort, France, revealed several deficiencies in the validation, production, and quality control of enoxaparin sodium pre-filled syringes. Observations included inadequate operator gowning, lack of written media fill requirements, insufficient verification during compounding, and issues with batch record integrity. The firm also had deficiencies in cleaning validation, revalidation protocols, out-of-specification procedures, and the conditional release of incoming materials.

## Related Officers

- [Rev T. Ou](https://www.globalkeysolutions.net/people/rev-t-ou/8d22c019-3d2e-443d-aa19-e046206286b7)
- [GEORGE FLYNN](https://www.globalkeysolutions.net/people/george-flynn/8e42726f-ade5-4857-8d8c-705c8ee254be)

Company: https://www.globalkeysolutions.net/companies/rhone-poulenc-rorer/4434ff6e-5ac4-4753-a844-dca05419012d

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