# FDA 483 - Patheon Puerto Rico, Inc. - July 12, 2022

Source: https://www.globalkeysolutions.net/records/483/patheon-puerto-rico-inc/264f9f13-3905-4bbe-b8df-0d23061cca38

> FDA 483 for Patheon Puerto Rico, Inc. on July 12, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Puerto Rico, Inc.
- Inspection Date: 2022-07-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Patheon Puerto Rico, Inc. in Manati, PR, revealed significant deficiencies in their quality system and facility maintenance. The firm failed to follow established production and process control procedures and had deficient standard operating procedures. Additionally, the facility exhibited poor maintenance with water leakage and potential mold in the raw materials warehouse.

## Related Documents

- [483 - 2018-05-31](https://www.globalkeysolutions.net/records/483/patheon-puerto-rico-inc/03e334e1-6c2a-4814-bb60-10a3eb26a37a)
- [483 - 2019-10-15](https://www.globalkeysolutions.net/records/483/patheon-puerto-rico-inc/c394fc2c-18ad-4917-b21e-8a0d16fe1773)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.globalkeysolutions.net/companies/patheon-puerto-rico-inc/e9addf1c-234e-45b2-a136-75152851936b

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