# FDA 483 - University Instrumentation Center at UNH - December 05, 2023

Source: https://www.globalkeysolutions.net/records/483/university-instrumentation-center-at-unh/b37cc653-6a03-423b-a632-f8416637819a

> FDA 483 for University Instrumentation Center at UNH on December 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Instrumentation Center at UNH
- Inspection Date: 2023-12-05
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: The University Instrumentation Center at UNH in Durham, NH, received a Form 483 with four observations primarily concerning data integrity and laboratory control deficiencies related to Nuclear Magnetic Resonance (NMR) spectroscopy. The firm failed to implement adequate computer system controls, ensure proper data review, validate test methods, and qualify equipment, indicating significant issues in their quality control and data management practices. These issues could compromise the reliability and accuracy of their analytical testing services.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)
- [Deputy Director](https://www.globalkeysolutions.net/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

Company: https://www.globalkeysolutions.net/companies/university-instrumentation-center-at-unh/38b6fd6a-8a8f-4955-ba24-b17c24b5efa5

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7