# FDA 483 - Zoetis LLC - September 29, 2023

Source: https://www.keypedia.com/records/483/zoetis-llc/a6312a46-c166-4171-81d0-ca3f6c8bbfae

> FDA 483 for Zoetis LLC on September 29, 2023. Product: veterinary. 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: veterinary
- Office Name: Office of Compliance Intervention and Consultation
- Summary: During an inspection conducted from September 25-29, 2023, the Food and Drug Administration (FDA) issued a Form 483 to Zoetis LLC, an API (Biotech) Manufacturer located in Lincoln, NE. The inspection revealed a significant observation concerning the integrity of laboratory control records. Specifically, the FDA noted that Zoetis LLC's laboratory control records are not adequately protected to ensure they contain complete and unaltered data from all tests performed to verify compliance with established specifications and standards. The inspection highlighted that data acquisition software and workstations, including those used for protein concentration determination and biological assays, were not sufficiently maintained. This allowed analysts to manually manipulate or delete testing data from the computer system, affecting the reliability of data generated for in-process and finished product bulk drug substances. This observation indicates a deficiency in maintaining data integrity, a critical aspect of Good Manufacturing Practices (GMP) under the Federal Food, Drug, and Cosmetic Act. Zoetis LLC is expected to address this issue by implementing robust corrective and preventive actions to ensure the security, completeness, and accuracy of all laboratory data, thereby preventing unauthorized alterations and ensuring compliance with regulatory requirements for product quality and safety.

## Related Documents

- [483 - 2015-01-14](https://www.keypedia.com/records/483/zoetis-llc/2fa23270-cd68-49f6-ac0c-4f6e9f5822fc)
- [483 - 2022-05-23](https://www.keypedia.com/records/483/zoetis-llc/72acab87-4b74-4d52-84c0-5d6d8fe8e8c5)
- [483 - 2023-09-29](https://www.keypedia.com/records/483/zoetis-llc/9a68f3f0-ea29-4073-9eac-0040122a3485)

## Related Officers

- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Christopher M. Klein](https://www.keypedia.com/people/christopher-m-klein/759ed06b-6416-4238-85ec-e1e8c7106321)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54