# FDA 483 - Rhône-Poulenc Chemie - July 08, 1997

Source: https://www.keypedia.com/records/483/rhone-poulenc-chemie/038b6d17-0fdb-4a60-be52-f9ba5b6c78ee

> FDA 483 for Rhône-Poulenc Chemie on July 08, 1997. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rhône-Poulenc Chemie
- Inspection Date: 1997-07-08
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of RHONE-POULENC CHEMIE in Rousillon, France, revealed several deficiencies related to manufacturing controls and data integrity. Observations included a lack of written sanitation and sampling procedures, an absence of a formalized Master Production Record, and laboratory raw data being recorded on unbound, loose sheets of paper. These issues indicate a need for improved documentation and control over manufacturing processes and data handling.

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Company: https://www.keypedia.com/companies/rhone-poulenc-chemie/a6b817d4-60fc-4752-86e3-d88cb3fc260f

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