# FDA 483 - Zydus Animal Health and Investments Limited - September 23, 2022

Source: https://www.keypedia.com/records/483/zydus-animal-health-and-investments-limited/0230cae0-8680-41ac-9188-404a9bd0f17c

> FDA 483 for Zydus Animal Health and Investments Limited on September 23, 2022. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Animal Health and Investments Limited
- Inspection Date: 2022-09-23
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Summary: Zydus Animal Health and Investments Limited in Ahmedabad, Gujarat, India, was cited with two observations during an FDA inspection. The inspection revealed issues with the investigation and resolution of unexplained discrepancies, particularly concerning out-of-specification results and contamination in their (b)(4) manufacturing system. Additionally, the firm's (b)(4) manufacturing system was found to lack a meaningful sampling plan and exhibited defects, including inadequate maintenance and sampling at points of use.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.keypedia.com/companies/zydus-animal-health-and-investments-limited/6ee7ae45-9697-481a-9899-ca397a4ed653

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