# FDA 483 - Tianish Laboratories Private Limited - June 05, 2019

Source: https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/fc1fbb08-9ad0-422c-ab6c-497b290bd248

> FDA 483 for Tianish Laboratories Private Limited on June 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianish Laboratories Private Limited
- Inspection Date: 2019-06-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited, an API manufacturer in Vizianagaram, India, was cited for significant deficiencies in its manufacturing and quality control processes. The inspection revealed inadequate procedures for preventing contamination and cross-contamination, insufficient investigations into impurity issues, and poorly validated cleaning processes for non-dedicated equipment. Additionally, the firm failed to properly store production equipment and demonstrated critical shortcomings in laboratory testing, instrument calibration, and qualification.

## Related Documents

- [483 - 2018-12-10](https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/43ded1bd-5aa7-4a90-af85-e84043884097)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Miguel A. Martinez](https://www.globalkeysolutions.net/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)

Company: https://www.globalkeysolutions.net/companies/tianish-laboratories-private-limited/7b05f5f2-461b-4a95-bfaa-a8c773250712

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