# FDA 483 - Patheon Puerto Rico, Inc. - October 15, 2019

Source: https://www.keypedia.com/records/483/patheon-puerto-rico-inc/c394fc2c-18ad-4917-b21e-8a0d16fe1773

> FDA 483 for Patheon Puerto Rico, Inc. on October 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Puerto Rico, Inc.
- Inspection Date: 2019-10-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Patheon part of Thermo Fisher in Manati, PR, was inspected from October 1-15, 2019, and received a Form 483 with two observations. The firm failed to thoroughly review unexplained discrepancies related to Levothyroxine Sodium Tablets and did not follow established production and process control procedures for Janumet Tablets. These issues indicate deficiencies in quality system and production control functions.

## Related Documents

- [483 - 2018-05-31](https://www.keypedia.com/records/483/patheon-puerto-rico-inc/03e334e1-6c2a-4814-bb60-10a3eb26a37a)
- [483 - 2022-07-12](https://www.keypedia.com/records/483/patheon-puerto-rico-inc/264f9f13-3905-4bbe-b8df-0d23061cca38)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [Jose R Flores-Veguilla](https://www.keypedia.com/people/jose-r-flores-veguilla/e048ce78-9ed3-479c-be29-31471900e258)

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

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