# FDA 483 - Zoetis LLC - May 03, 2021

Source: https://www.globalkeysolutions.net/records/483/zoetis-llc/ccde9ea4-bca5-4e1a-80f1-e7df04653681

> FDA 483 for Zoetis LLC on May 03, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Zoetis LLC
- Inspection Date: 2021-05-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: This FDA Form 483 was issued to Zoetis LLC in Kalamazoo, MI, following an inspection of their drug manufacturing facility. The inspection revealed significant deficiencies primarily in aseptic processing, including environmental monitoring, cleaning, and contamination prevention. Additional concerns were raised regarding the quality control unit's authority and procedures, manufacturing process validation, and facility sanitation due to insect infestation.

## Related Officers

- [Bei Y. He](https://www.globalkeysolutions.net/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)
- [Franklin D Drielex](https://www.globalkeysolutions.net/people/franklin-d-drielex/9f55710e-1ea3-4377-92f7-2f5747e682af)
- [Investigator](https://www.globalkeysolutions.net/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)
- [Peng Zhou](https://www.globalkeysolutions.net/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

Company: https://www.globalkeysolutions.net/companies/zoetis-llc/68795e53-f0f7-457d-b431-b71aca989688

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0