# FDA 483 - Unilab Chemicals and Pharmaceuticals Private Ltd. - November 18, 2019

Source: https://www.keypedia.com/records/483/unilab-chemicals-and-pharmaceuticals-private-ltd/c25eab68-bb6c-4aa9-b2d9-0cd09bce6284

> FDA 483 for Unilab Chemicals and Pharmaceuticals Private Ltd. on November 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unilab Chemicals and Pharmaceuticals Private Ltd.
- Inspection Date: 2019-11-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Unilab Chemicals and Pharmaceuticals Pvt. Ltd. in Dombivli, India, was inspected by the FDA from November 18-22, 2019, and received seven observations. The inspection revealed significant deficiencies in quality management, laboratory controls, materials management, and process equipment. Key issues included inadequate record-keeping, unapproved master production instructions, failure to investigate customer complaints, insufficient stability data, unsound sampling plans, unsuitable water for API manufacturing, and ineffective equipment cleaning.

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)

Company: https://www.keypedia.com/companies/unilab-chemicals-and-pharmaceuticals-private-ltd/4527d913-752e-4f0a-b281-5ec30695ede9

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