# FDA 483 - Alivira Animal Health Limited - September 18, 2023

Source: https://www.globalkeysolutions.net/records/483/alivira-animal-health-limited/e3aa4ab9-e7e7-4a0d-811d-416b677a6cdf

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

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## Details

- Record Type: 483
- Company Name: Alivira Animal Health Limited
- Inspection Date: 2023-09-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Alvira Animal Health Limited, an Active Pharmaceutical Ingredient Manufacturer in Visakhapatnam, India, revealed a significant issue regarding quality control. The firm failed to adequately document and review critical in-process and laboratory test results within their Batch Manufacturing Records for API finished products. This indicates a potential systemic problem with data integrity and quality assurance processes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/luis-a-carrion/844cdfeb-654d-4d27-bbcd-712b9036fd00)

Company: https://www.globalkeysolutions.net/companies/alivira-animal-health-limited/8bb7e2de-7191-4fee-8834-335e5a8cd50e

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1