# FDA 483 - Coral Pharmaceuticals LTD - May 24, 2019

Source: https://www.keypedia.com/records/483/coral-pharmaceuticals-ltd/fb75e945-dad8-4ecf-8584-5843073c7edc

> FDA 483 for Coral Pharmaceuticals LTD on May 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coral Pharmaceuticals LTD
- Inspection Date: 2019-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Coral Pharmaceuticals LTD, a homeopathic drug manufacturer in Freeport City Bahamas, was cited for significant deficiencies across its quality control, equipment, production, and laboratory control systems. The inspection revealed a pervasive lack of written procedures, inadequate training, insufficient quality oversight, and failures in equipment qualification, calibration, and product testing, indicating a fundamental breakdown in cGMP compliance.

## Related Documents

- [WARNING_LETTER - 2019-05-24](https://www.keypedia.com/records/warning_letter/coral-pharmaceuticals-ltd/be324400-2453-4732-b2e9-b6756cf4c5d7)

## Related Officers

- [Kenneth H. Williams](https://www.keypedia.com/people/kenneth-h-williams/20a225cd-a3d5-478f-ae04-2a8e119df8a6)
- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/coral-pharmaceuticals-ltd/24ae84dc-a870-4b26-96c3-163b4e8c263f

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