# FDA 483 - Patheon Puerto Rico, Inc. - May 31, 2018

Source: https://www.globalkeysolutions.net/records/483/patheon-puerto-rico-inc/03e334e1-6c2a-4814-bb60-10a3eb26a37a

> FDA 483 for Patheon Puerto Rico, Inc. on May 31, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Puerto Rico, Inc.
- Inspection Date: 2018-05-31
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Patheon Puerto Rico, Inc., a drug product manufacturer in Manati, PR, revealed significant deficiencies in their quality control systems. The firm failed to thoroughly investigate out-of-specification results with scientific rationale and lacked adequate laboratory controls to ensure accurate test results. Additionally, the inspection found that unlabeled drug product containers were mishandled, leading to multiple consumer complaints about missing lot numbers and expiration dates on distributed products.

## Related Documents

- [483 - 2019-10-15](https://www.globalkeysolutions.net/records/483/patheon-puerto-rico-inc/c394fc2c-18ad-4917-b21e-8a0d16fe1773)
- [483 - 2022-07-12](https://www.globalkeysolutions.net/records/483/patheon-puerto-rico-inc/264f9f13-3905-4bbe-b8df-0d23061cca38)

## Related Officers

- [Libia Lugo](https://www.globalkeysolutions.net/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9