# FDA 483 - Unilab Chemicals and Pharmaceuticals Private Ltd. - February 27, 2026

Source: https://www.keypedia.com/records/483/unilab-chemicals-and-pharmaceuticals-private-ltd/a079994a-782f-418b-acac-04cf84434b7e

> FDA 483 for Unilab Chemicals and Pharmaceuticals Private Ltd. on February 27, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Unilab Chemicals and Pharmaceuticals Private Ltd.
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Unilab Chemicals and Pharmaceuticals Private Ltd. in Mumbai, India, revealed significant deficiencies in its API manufacturing processes. The firm failed to ensure supplier reliability, adequately investigate discrepancies, maintain proper quality control documentation, and provide sufficient GMP training. A repeat observation highlighted persistent issues with equipment cleaning, indicating a lack of control over contamination prevention.

## Related Documents

- [483 - 2019-11-18](https://www.keypedia.com/records/483/unilab-chemicals-and-pharmaceuticals-private-ltd/c25eab68-bb6c-4aa9-b2d9-0cd09bce6284)
- [483 - 2019-11-18](https://www.keypedia.com/records/483/unilab-chemicals-and-pharmaceuticals-private-ltd/b0ac1c5e-863c-4c2c-896e-5afebce0478c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8