# FDA 483 - Teva Puerto Rico LLC - March 03, 2017

Source: https://www.keypedia.com/records/483/teva-puerto-rico-llc/d06f1b78-3ffc-4414-a770-12523ef62c27

> FDA 483 for Teva Puerto Rico LLC on March 03, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Teva Puerto Rico LLC
- Inspection Date: 2017-03-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Warner Chilcott Company LLC in Fajardo, PR, revealed two significant observations related to manufacturing practices. The firm failed to follow established procedures for stability sample packaging and lacked adequate procedures to prevent microbiological contamination during in-process sampling of non-sterile drug products. These deficiencies indicate a need for improved adherence to and establishment of robust quality control procedures.

## Related Documents

- [483 - 2022-11-23](https://www.keypedia.com/records/483/teva-puerto-rico-llc/66e48599-c92b-4add-8105-2c0e07376ac8)

## Related Officers

- [Yuexin Wang](https://www.keypedia.com/people/yuexin-wang/c5e4270f-2418-4b49-84de-4dc2870284f8)
- [FDA Investigator/SJN-DO Pre-Approval Program Manager](https://www.keypedia.com/people/german-rivera/da06570b-3a79-44b3-8870-5760cee60df0)

Company: https://www.keypedia.com/companies/teva-puerto-rico-llc/1ed3f946-be5e-473a-ae76-ac9abcde2d21

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