# FDA 483 - CGA Limited - May 31, 2019

Source: https://www.globalkeysolutions.net/records/483/cga-limited/aef149e5-019c-4ef3-a94b-403ea4010a5a

> FDA 483 for CGA Limited on May 31, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CGA Limited
- Inspection Date: 2019-05-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of CGA Limited, an OTC drug manufacturer in Laventille Trinidad & Tobago, revealed significant deficiencies across its quality control, production, and laboratory systems. Observations included a lack of written procedures, inadequate investigations into failing batches, unmaintained and unvalidated equipment, and insufficient testing and documentation for product release and stability. These issues indicate a systemic failure to adhere to current Good Manufacturing Practices.

## Related Documents

- [WARNING_LETTER - 2019-05-31](https://www.globalkeysolutions.net/records/warning_letter/cga-limited/385701ab-4a87-42f7-a043-c76315ba853a)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/cga-limited/629d3e6f-774a-4fe1-9246-b0cc33a4ef32

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