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

Source: https://www.globalkeysolutions.net/records/483/nakoda-chemicals-ltd/18b813a9-d288-4721-adec-4d4151d91f52

> FDA 483 for Nakoda Chemicals Ltd. on January 18, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nakoda Chemicals Ltd.
- Inspection Date: 2016-01-18
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Jennifer L Gustavus, Investigator](https://www.globalkeysolutions.net/people/jennifer-l-gustavus-investigator/480fbcf7-7ce3-4887-ac7d-c102735d80f4)
- [Drug Investigator](https://www.globalkeysolutions.net/people/deyaa-shaheen/ebbabce5-347c-4de4-abed-ba9da11c26ed)

Company: https://www.globalkeysolutions.net/companies/nakoda-chemicals-ltd/b6c3bf44-9116-41ff-9516-6828d413dba3

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd