Nakoda Chemicals Ltd.January 18, 2016

FDA 483 - Nakoda Chemicals Ltd. - January 18, 2016

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Record Details

An FDA inspection of Nakoda Chemicals LTD. in Hyderabad, India, from January 18-22, 2016, revealed a significant quality control issue. The firm failed to verify test methods and procedures used for the release of finished products, specifically the (b)(4) USP finished product. This indicates a lack of proper validation for critical manufacturing processes.

Company: Nakoda Chemicals Ltd.
Inspection Date: January 18, 2016
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Jennifer L. Gustavus
Deyaa Shaheen (Drug Investigator)

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ID · 18b813a9-d288-4721-adec-4d4151d91f52