# FDA 483 - Zoetis LLC - September 29, 2023

Source: https://www.globalkeysolutions.net/records/483/zoetis-llc/9a68f3f0-ea29-4073-9eac-0040122a3485

> FDA 483 for Zoetis LLC on September 29, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoetis LLC
- Inspection Date: 2023-09-29
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Zoetis LLC in Lincoln, NE was inspected by the FDA from September 25-29, 2023. The inspection revealed significant data integrity concerns regarding laboratory control records, where testing data could be manually manipulated or deleted from the computer system. This indicates a serious lapse in ensuring complete and reliable data for product testing.

## Related Documents

- [483 - 2015-01-14](https://www.globalkeysolutions.net/records/483/zoetis-llc/2fa23270-cd68-49f6-ac0c-4f6e9f5822fc)
- [483 - 2022-05-23](https://www.globalkeysolutions.net/records/483/zoetis-llc/72acab87-4b74-4d52-84c0-5d6d8fe8e8c5)

## Related Officers

- [Joohi Castelvetere](https://www.globalkeysolutions.net/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.globalkeysolutions.net/companies/zoetis-llc/1ea95bb9-fb5b-458d-bfff-ca0195c13aa6

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8