# FDA 483 - Fareva Amboise - May 25, 2018

Source: https://www.keypedia.com/records/483/fareva-amboise/db4ab0c8-17a5-421f-8a0a-a9247c322ddc

> FDA 483 for Fareva Amboise on May 25, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fareva Amboise
- Inspection Date: 2018-05-25
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Fareva Amboise, a drug manufacturer in Poce Sur Cisse, France, received a Form 483 for significant quality control and production deficiencies. The inspection revealed issues including inadequate vendor qualification, missing material specifications, unvalidated processes, and insufficient controls over computer systems and facility operations. These observations collectively indicate a lack of assurance regarding drug product identity, strength, quality, and purity.

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## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/fareva-amboise/4d8ebbcc-2e13-4584-b144-63aa8191bc92

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4