University Of Michigan
Form 483 issued December 3, 2018 · Ann Arbor, Michigan
- Inspection
- Dec 3, 2018
- Investigator
- Emily J. Orban
- Observations
- 5
- Pages
- 3
- FEI number
- 3003531601
In short: On December 3, 2018, FDA issued a Form 483 with 5 observations to University Of Michigan in Ann Arbor, Michigan (FEI 3003531601) after an inspection that ran Dec 3, 2018. The investigator was Emily J. Orban. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Materials or supplies were not disinfected prior to entering…
- 02
Personnel moved rapidly in the vicinity of instrnments, which disrnpted the airflow and increased the risk…
- 03
Personnel engaged in aseptic processing were observed with exposed hands, exposed wrists, exposed legs, exposed…
- 04
Your facility was designed and/or operated in a way that permits…
This inspection in context
Emily J. Orban
19 documents · 2012–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmUniversity Of Michigan history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University Of Michigan?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected University Of Michigan?
Emily J. Orban is named on this Form 483, for the inspection of Dec 3, 2018. Each investigator has a profile showing what they cite most.
When was University Of Michigan inspected by FDA?
The inspection ran Dec 3, 2018, and the Form 483 is dated December 3, 2018.
How do I get the full Form 483 for University Of Michigan?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.