# FDA 483 - Chromo Laboratories India Private Limited - August 10, 2024

Source: https://www.keypedia.com/records/483/chromo-laboratories-india-private-limited/49ae002d-51b0-4d95-ab93-249ae7340d14

> FDA 483 for Chromo Laboratories India Private Limited on August 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chromo Laboratories India Private Limited
- Inspection Date: 2024-08-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Chromo Laboratories India PVT. LTD. in Patancheru Mandel, India, was inspected and received a Form 483 with 9 observations. The inspection revealed significant deficiencies across quality control, quality unit oversight, equipment maintenance, record management, environmental controls, and employee training. These issues indicate a systemic failure to adhere to GMP requirements for the manufacture and storage of intermediates and APIs.

## Related Documents

- [483 - 2020-01-24](https://www.keypedia.com/records/483/chromo-laboratories-india-private-limited/52081153-2f0a-4a05-9b17-f7fe904a592c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.keypedia.com/companies/chromo-laboratories-india-private-limited/2ad9e1f0-45cb-4dde-bab5-26579c1ca5e2

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