# FDA 483 - Vetio Animal Health - August 18, 2023

Source: https://www.keypedia.com/records/483/vetio-animal-health/c100a0a4-5e16-447e-a223-e71cfcf3282b

> FDA 483 for Vetio Animal Health on August 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vetio Animal Health
- Inspection Date: 2023-08-18
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Vetio Animal Health in Saint-Laurent, a drug manufacturer, revealed significant deficiencies across multiple quality systems. Observations included inadequate computer system controls leading to unauthorized data modifications, a failure to properly investigate and classify numerous discrepancies, and a lack of timely calibration for critical manufacturing and QC equipment. Additionally, the firm failed to follow written procedures for master production records and ensure contemporaneous record-keeping, and drug products were not stored under appropriate temperature and humidity controls with real-time monitoring.

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/vetio-animal-health/7b019ca7-7830-408c-a1f0-bc4a533fd9a4

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