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

Source: https://www.keypedia.com/records/483/zen-chemicals-private-limited/de0355e5-36cd-4cc9-831a-900944988c0a

> 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 Inspections and Investigations
- Summary: An FDA inspection conducted at Zen Chemicals Pvt. Ltd. in Dombivili, Maharashtra, India, from March 23-28, 2023, revealed significant deficiencies in their manufacturing and quality control operations, as outlined in a Form FDA 483 report. The firm, a critical API intermediate manufacturer, was cited for multiple violations under the Federal Food, Drug and Cosmetic Act. Key issues included a lack of proper equipment cleaning and sanitization, evidenced by visible product and rust residues on supposedly cleaned, non-dedicated equipment and the absence of established clean/dirty hold times and cleaning verification. The FDA also noted a failure to conduct thorough investigations into repeated analytical sample reruns and inconsistent data generation from laboratory instruments. Furthermore, the inspection found inadequate controls over computerized systems, such as the absence of audit trails on some equipment, shared user credentials with data manipulation capabilities, and a deficient electronic data backup system that overwrites previous data without quality assurance verification. The company also failed to perform required Performance Qualification for several pieces of equipment and had inadequate training records for employees responsible for critical cleaning procedures, contributing to the observed contamination issues. Zen Chemicals Pvt. Ltd. is required to address these observations with corrective actions to ensure compliance.

## Related Documents

- [483 - 2023-03-28](https://www.keypedia.com/records/483/zen-chemicals-private-limited/97a742ad-d444-4ec0-8d72-fbe3d97275eb)
- [483 - 2023-03-28](https://www.keypedia.com/records/483/zen-chemicals-private-limited/9a4704b3-5ee4-441d-a94d-9672a09305ae)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8