# FDA 483 - Intas Pharmaceuticals Limited - June 08, 2018

Source: https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-limited/6c433282-acc9-4639-89b9-e51ca154262e

> FDA 483 for Intas Pharmaceuticals Limited on June 08, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Limited
- Inspection Date: 2018-06-08
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Intas Pharmaceuticals Limited in Ahmedabad, India, a sterile drug manufacturer, received a Form FDA 483 with two observations. The inspection revealed deficiencies in the environmental monitoring system for sterile drug processing areas, including issues with barrier system studies, media fills, and sterilization process validation. Additionally, the firm failed to thoroughly investigate unexplained discrepancies and equipment failures, as evidenced by several inadequate deviation reports.

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## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.globalkeysolutions.net/companies/intas-pharmaceuticals-limited/0db00702-d7f6-4a8b-87d1-1b32ac236cc8

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4