Alivira Animal Health LimitedSeptember 18, 2023

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

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Record Details

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.

Company: Alivira Animal Health Limited
Inspection Date: September 18, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Luis A. Carrion (investigator)

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ID · e3aa4ab9-e7e7-4a0d-811d-416b677a6cdf