# FDA 483 - Cambridge Isotope Laboratories, Inc. - March 25, 2016

Source: https://www.globalkeysolutions.net/records/483/cambridge-isotope-laboratories-inc/5dce12cf-c381-49af-951f-b930ec3e922e

> FDA 483 for Cambridge Isotope Laboratories, Inc. on March 25, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambridge Isotope Laboratories, Inc.
- Inspection Date: 2016-03-25
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Cambridge Isotope Laboratories, Inc. in Andover, MA, an API manufacturer, was cited for significant deficiencies in its quality unit's oversight and investigation processes, as well as inadequate control over critical manufacturing equipment and processes for C-13 UREA API. The inspection revealed issues with non-conformance investigations, change control management, purification column quality assurance, and maintenance programs for critical valves and cylinders. These observations indicate a need for improved quality system controls to ensure product safety and quality.

## Related Documents

- [483 - 2022-08-30](https://www.globalkeysolutions.net/records/483/cambridge-isotope-laboratories-inc/3ec74dfe-9d37-40af-8425-fe62bebcfaaf)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stacey-s-degarmo/f0dea08e-f65f-4664-9614-66f1997a95dc)

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

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