# FDA 483 - RUBICON RESEARCH LIMITED - January 27, 2023

Source: https://www.keypedia.com/records/483/rubicon-research-limited/493779a8-787c-429a-ad84-dea9aef52044

> FDA 483 for RUBICON RESEARCH LIMITED on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RUBICON RESEARCH LIMITED
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Rubicon Research Private Limited, a liquid oral dose finished drug manufacturer in Satara, India, was cited for significant deficiencies during an FDA inspection. The observations include inadequate laboratory controls for out-of-specification results, incomplete validation of critical manufacturing processes like bottle sealing, and plumbing system defects that pose a contamination risk. These issues indicate potential compromises to drug product quality and purity.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.keypedia.com/companies/rubicon-research-limited/118f747f-e637-4112-bc70-6d016fdf3185

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