# FDA 483 - Teva API India Ltd- Malanpur - April 16, 2019

Source: https://www.globalkeysolutions.net/records/483/teva-api-india-ltd-malanpur/b780b5fc-9af0-4f8a-9029-cc007329ef25

> FDA 483 for Teva API India Ltd- Malanpur on April 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva API India Ltd- Malanpur
- Inspection Date: 2019-04-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Teva API India Pvt. Ltd. revealed significant deficiencies across its operations. The firm failed to conduct adequate risk assessments for impurities in Key Starting Materials and lacked properly validated cleaning processes for non-dedicated equipment. Additionally, the Quality Unit did not consistently follow its own procedures, and production equipment was stored in conditions that risked contamination.

## Related Officers

- [Anita Tiwari](https://www.globalkeysolutions.net/people/anita-tiwari/baaf3af5-24c6-4865-9b30-10c1aa375932)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/teva-api-india-ltd-malanpur/3a0b73ee-8e64-412f-9050-71e089560b19

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1