# FDA 483 - Rhone-Poulenc Rorer Puerto Rico, Inc. - September 23, 2099

Source: https://www.keypedia.com/records/483/rhone-poulenc-rorer-puerto-rico-inc/ee075395-ee8c-4af7-9f11-b5940e6d6ef7

> FDA 483 for Rhone-Poulenc Rorer Puerto Rico, Inc. on September 23, 2099. 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: 2099-09-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: This FDA Form 483 report for RHONE-POULENC RORER P.R. INC. in Manati, Puerto Rico, details significant deficiencies in quality control, laboratory operations, and timely regulatory reporting. The inspection revealed issues across multiple drug products, including failures in stability testing, supplier qualification, and computer system validation, indicating a systemic lack of adherence to good manufacturing practices and regulatory requirements.

## Related Documents

- [483 - 2000-02-10](https://www.keypedia.com/records/483/rhone-poulenc-rorer-puerto-rico-inc/6b0c51b3-63b1-4fa3-835b-217e11aef3f0)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/margarita-santiago/55412217-fc75-4cdc-82a6-83611a261d3e)
- [Jorge L. Guadalupe](https://www.keypedia.com/people/jorge-l-guadalupe/5dd31936-36dd-42f6-a9f6-a9bdbe4255a1)

Company: https://www.keypedia.com/companies/rhone-poulenc-rorer-puerto-rico-inc/ca6a1746-61e0-4ec5-8c60-a86ab251c8ce

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6