# FDA 483 - Zen Chemicals Private Limited - March 28, 2023

Source: https://www.globalkeysolutions.net/records/483/zen-chemicals-private-limited/9a4704b3-5ee4-441d-a94d-9672a09305ae

> FDA 483 for Zen Chemicals Private Limited on March 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zen Chemicals Private Limited
- Inspection Date: 2023-03-28
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Zen Chemicals Pvt. Ltd. in Dombivili, India, was cited for significant deficiencies in equipment cleaning and sanitation, data integrity, and quality system controls. The inspection revealed visibly dirty equipment, a lack of investigations into analytical data discrepancies, inadequate computer system access controls, and untrained cleaning personnel. These issues indicate a serious breakdown in maintaining a state of control for critical API intermediate manufacturing.

## Related Documents

- [483 - 2023-03-28](https://www.globalkeysolutions.net/records/483/zen-chemicals-private-limited/de0355e5-36cd-4cc9-831a-900944988c0a)
- [483 - 2023-03-28](https://www.globalkeysolutions.net/records/483/zen-chemicals-private-limited/97a742ad-d444-4ec0-8d72-fbe3d97275eb)

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/zen-chemicals-private-limited/b3d757ae-d4d3-4247-a222-e08b10198434

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