# FDA 483 - Zoetis, LLC - January 09, 2017

Source: https://www.globalkeysolutions.net/records/483/zoetis-llc/b55955be-a267-4616-a231-c075d90a2e88

> FDA 483 for Zoetis, LLC on January 09, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoetis, LLC
- Inspection Date: 2017-01-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Zoetis LLC in Willow Island, WV, an API and Type A Medicated Articles manufacturer, revealed four observations. The firm failed to thoroughly review unexplained discrepancies, lacked appropriate controls over computer systems, and did not have established procedures for QC laboratory equipment maintenance. Additionally, active pharmaceutical ingredients and medicated articles were not stored under controlled conditions consistent with product labels.

## Related Officers

- [Steven P Donald](https://www.globalkeysolutions.net/people/steven-p-donald/431cb518-7687-408b-82e4-e525a135a26b)
- [Drug Investigator](https://www.globalkeysolutions.net/people/deyaa-shaheen/ebbabce5-347c-4de4-abed-ba9da11c26ed)

Company: https://www.globalkeysolutions.net/companies/zoetis-llc/5ccd1160-aa7e-4c73-be94-1e0cd806377b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e