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

Source: https://www.globalkeysolutions.net/records/483/zen-chemicals-private-limited/97a742ad-d444-4ec0-8d72-fbe3d97275eb

> 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: Office of Biological Products Operations - Division I
- Summary: Zen Chemicals Pvt. Ltd., a critical API intermediate manufacturer in Dombivili, India, received a Form 483 citing significant deficiencies during an FDA inspection. Observations included inadequate equipment cleaning and sanitization, a failure to investigate multiple analytical sample reruns, and insufficient controls over computerized laboratory systems. Additionally, the firm neglected to perform equipment qualification and ensure proper employee training in cleaning procedures, indicating systemic quality control issues.

## 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/9a4704b3-5ee4-441d-a94d-9672a09305ae)

## 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/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1