# FDA 483 - Teva API India Private Ltd. - February 09, 2018

Source: https://www.keypedia.com/records/483/teva-api-india-private-ltd/e08ae228-0589-47e5-9b19-20d7923f3eaa

> FDA 483 for Teva API India Private Ltd. on February 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva API India Private Ltd.
- Inspection Date: 2018-02-09
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Teva API India Pvt. Ltd. in Gajraula, India, a non-sterile API manufacturer, identified critical deficiencies in quality control. The firm failed to store drug substances under appropriate temperature conditions and lacked a proper pest control program. Additionally, inadequate investigations into manufacturing deviations and poorly designed equipment hindering cleaning were noted, indicating a risk to the identity, strength, quality, and purity of drug substances.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.keypedia.com/companies/teva-api-india-private-ltd/aeeb5a05-7558-44f6-a08a-bb2f3d1aa3de

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