# Patheon Puerto Rico, Inc. – FDA 483, Jul 31, 2026

Source: https://www.keypedia.com/records/483/patheon-puerto-rico-inc/3187c49f-7b57-44fd-a65d-9e6ca4763f9a

> FDA 483 for Patheon Puerto Rico, Inc. on July 31, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Puerto Rico, Inc.
- Inspection Date: 2026-07-31
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: An FDA inspection of Patheon Puerto Rico, Inc. in Manati, PR, revealed significant deficiencies in quality control and adherence to written procedures. The firm failed to adequately test incoming high-risk drug components and lacked scientific justification for its sampling methods. Additionally, production operators did not properly document sample collection times as required by established procedures, indicating a breakdown in process control.

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- [483 - 2022-07-12](https://www.keypedia.com/records/483/patheon-puerto-rico-inc/264f9f13-3905-4bbe-b8df-0d23061cca38) — date: July 12, 2022
- [483 - 2019-10-15](https://www.keypedia.com/records/483/patheon-puerto-rico-inc/c394fc2c-18ad-4917-b21e-8a0d16fe1773) — date: October 15, 2019
- [483 - 2018-05-31](https://www.keypedia.com/records/483/patheon-puerto-rico-inc/03e334e1-6c2a-4814-bb60-10a3eb26a37a) — date: May 31, 2018

## Related Officers

- [Christian F. Gomez Lugo](https://www.keypedia.com/people/christian-f-gomez-lugo/866e531a-6354-45b2-8e43-1dfc9d146caf)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

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

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