Zydus Animal Health and Investments Limited – FDA 483, Sep 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.
- Inspection date
- September 23, 2022
- Product type
- veterinary
ID · 0230cae0-8680-41ac-9188-404a9bd0f17c
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