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

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.