# FDA 483 - Cambridge Isotope Laboratories, Inc. - August 30, 2022

Source: https://www.keypedia.com/records/483/cambridge-isotope-laboratories-inc/3ec74dfe-9d37-40af-8425-fe62bebcfaaf

> FDA 483 for Cambridge Isotope Laboratories, Inc. on August 30, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambridge Isotope Laboratories, Inc.
- Inspection Date: 2022-08-30
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Cambridge Isotope Laboratories, Inc. in Andover, MA, an Active Pharmaceutical Ingredient Manufacturer, was cited for a significant quality control issue. The firm failed to adequately investigate an out-of-specification result for Loss on Drying (LOD) during accelerated stability studies for Urea (C13, 99%). This failure involved not evaluating the potential impact on long-term stability data or the container closure system, instead prematurely concluding the bottle was unsuitable.

## Related Documents

- [483 - 2016-03-25](https://www.keypedia.com/records/483/cambridge-isotope-laboratories-inc/5dce12cf-c381-49af-951f-b930ec3e922e)

## Related Officers

- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/cambridge-isotope-laboratories-inc/bb7d8566-a216-469b-88ac-a3fa0060927e

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94