# FDA 483 - Chromo Laboratories India Private Limited - January 24, 2020

Source: https://www.keypedia.com/records/483/chromo-laboratories-india-private-limited/52081153-2f0a-4a05-9b17-f7fe904a592c

> FDA 483 for Chromo Laboratories India Private Limited on January 24, 2020. 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: 2020-01-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food East V Compliance Branch
- Summary: Chromo Laboratories India PVT. LTD. in Patancheru Mandel, India, an intermediate and API manufacturer, received a Form FDA 483 with nine observations following an inspection from January 20-24, 2020. The observations highlight significant deficiencies across quality control, data integrity, analytical method transfer, stability studies, cleaning validation, equipment maintenance, environmental controls, and employee training. These issues indicate a broad lack of adherence to cGMP requirements, posing potential risks to product quality and patient safety.

## Related Documents

- [483 - 2024-08-10](https://www.keypedia.com/records/483/chromo-laboratories-india-private-limited/49ae002d-51b0-4d95-ab93-249ae7340d14)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-east-v-compliance-branch/00f6013b-7c92-4daf-ae51-d47ab44bf1cb