University Instrumentation Center at UNH
Form 483 issued December 5, 2023 · Durham, New Hampshire
- Inspection
- Nov 27 – Dec 5, 2023
- Investigators
- Edmund F. Mrak· Lori M. Newman
- Observations
- 4
- Pages
- 4
- FEI number
- 3002813858
In short: On December 5, 2023, FDA issued a Form 483 with 4 observations to University Instrumentation Center at UNH in Durham, New Hampshire (FEI 3002813858) after an inspection that ran Nov 27 – Dec 5, 2023. The investigators were Edmund F. Mrak and Lori M. Newman. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory records do not include the initials or signature of a second person showing that the…
- 03
The specificity of test methods have not…
- 04
Routine checking of electronic equipment is not performed according to a written program designed…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmUniversity Instrumentation Center at UNH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University Instrumentation Center at UNH?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected University Instrumentation Center at UNH?
Edmund F. Mrak and Lori M. Newman are named on this Form 483, for the inspection of Nov 27 – Dec 5, 2023. Each investigator has a profile showing what they cite most.
When was University Instrumentation Center at UNH inspected by FDA?
The inspection ran Nov 27 – Dec 5, 2023, and the Form 483 is dated December 5, 2023.
How do I get the full Form 483 for University Instrumentation Center at UNH?
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