# FDA 483 - Intervet International GmbH - April 28, 2023

Source: https://www.globalkeysolutions.net/records/483/intervet-international-gmbh/ab245aa2-4664-4aa6-85f4-bfb0852a37b6

> FDA 483 for Intervet International GmbH on April 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intervet International GmbH
- Inspection Date: 2023-04-28
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Intervet International GmbH, a manufacturer in Unterschleissheim, Bavaria, identified two significant observations. The firm was cited for inadequate control over access to label and labeling material storage, including unlocked cages and unattended label rolls. Additionally, the inspection found that the accuracy, sensitivity, specificity, and reproducibility of test methods were not established and documented, specifically regarding filtration test samples and stability chamber validation.

## Related Officers

- [GDUFA Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)
- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.globalkeysolutions.net/companies/intervet-international-gmbh/ae83e558-c533-4439-b820-58981fa727a2

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