# FDA 483 - Kekule Pharma Limited - March 15, 2024

Source: https://www.keypedia.com/records/483/kekule-pharma-limited/4930155b-0f5c-4d06-a85e-d8bc2d9dcb9f

> FDA 483 for Kekule Pharma Limited on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kekule Pharma Limited
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Kekule Pharma Limited in Sangareddy, Telangana, India, from March 11-15, 2024, revealed a significant lapse in quality control procedures. The firm failed to document, explain, and investigate deviations from established procedures, specifically regarding temperature excursions in a control sample storage room. This indicates a serious concern with the firm's quality management system and its ability to ensure product quality and integrity.

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

Company: https://www.keypedia.com/companies/kekule-pharma-limited/809f91ec-14d2-4a6a-aa5a-1f676ae5063b

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144