# FDA 483 - Ceva Animal Health - November 09, 2018

Source: https://www.keypedia.com/records/483/ceva-animal-health/0c18ea14-db75-4c57-8546-aae42beb7ec4

> FDA 483 for Ceva Animal Health on November 09, 2018. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ceva Animal Health
- Inspection Date: 2018-11-09
- Product Type: veterinary
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ceva Animal Health, LLC in Oldsmar, FL, was cited for significant quality system deficiencies during an FDA inspection from November 7-9, 2018. The firm failed to adequately investigate unexplained discrepancies, out-of-specification results, and complaints, often lacking conclusions, follow-up, risk assessments, and corrective actions. Additionally, the company did not perform required annual product reviews for its drug products.

## Related Officers

- [Saundra A. Munroe](https://www.keypedia.com/people/saundra-a-munroe/8e9b8973-5ac4-4a2a-ab26-1618c0e434e7)
- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/ceva-animal-health/dbc44c36-f6fc-4b1e-aa47-96ec53f8143e

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6