# FDA 483 - Rhone-Poulenc Rorer Puerto Rico, Inc. - February 10, 2000

Source: https://www.globalkeysolutions.net/records/483/rhone-poulenc-rorer-puerto-rico-inc/6b0c51b3-63b1-4fa3-835b-217e11aef3f0

> FDA 483 for Rhone-Poulenc Rorer Puerto Rico, Inc. on February 10, 2000. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rhone-Poulenc Rorer Puerto Rico, Inc.
- Inspection Date: 2000-02-10
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: An FDA inspection of Rhone-Poulenc Rorer Puerto Rico, Inc. in Manati, Puerto Rico, revealed significant deficiencies across multiple areas. The firm was cited for delayed field alerts and stability testing for Klaron Lotion, unvalidated computer software, and widespread issues with purified water quality control, including failure to perform required TOC analysis and implement corrective actions. Additionally, the firm failed to generate a chemical component release form and conducted an inadequate method transfer study.

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## Related Officers

- [Carlos A. Medina](https://www.globalkeysolutions.net/people/carlos-a-medina/1e357ab0-15fd-471f-a4df-28a519fdd2d7)
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Company: https://www.globalkeysolutions.net/companies/rhone-poulenc-rorer-puerto-rico-inc/ca6a1746-61e0-4ec5-8c60-a86ab251c8ce

Office: https://www.globalkeysolutions.net/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8