# FDA 483 - R. Mason (Chemicals), Ltd. - July 21, 2016

Source: https://www.keypedia.com/records/483/r-mason-chemicals-ltd/946507f5-a0f2-4a3b-843c-449322056c2e

> FDA 483 for R. Mason (Chemicals), Ltd. on July 21, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: R. Mason (Chemicals), Ltd.
- Inspection Date: 2016-07-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of R. Mason (Chemicals) Ltd., an API manufacturer in the United Kingdom, revealed significant deficiencies in their quality systems. The firm lacked an ongoing stability program for its API product, failed to validate cleaning procedures, and did not validate Certificates of Analysis for raw materials. Additionally, the company did not maintain adequate records for primary packaging material traceability.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.keypedia.com/companies/r-mason-chemicals-ltd/4f9a8a24-0f6e-4855-aed0-54cb1c4e177b

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8