University Of Michigan
Form 483 issued June 29, 2016 · Ann Arbor, Michigan
- Inspection
- Jun 6 – Jun 29, 2016
- Investigators
- Bei Y. He· Jeffrey D. Meng
- Observations
- 8
- Pages
- 6
- FEI number
- 3003531601
In short: On June 29, 2016, FDA issued a Form 483 with 8 observations to University Of Michigan in Ann Arbor, Michigan (FEI 3003531601) after an inspection that ran Jun 6 – Jun 29, 2016. The investigators were Bei Y. He and Jeffrey D. Meng. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University Of Michigan?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected University Of Michigan?
Bei Y. He and Jeffrey D. Meng are named on this Form 483, for the inspection of Jun 6 – Jun 29, 2016. Each investigator has a profile showing what they cite most.
When was University Of Michigan inspected by FDA?
The inspection ran Jun 6 – Jun 29, 2016, and the Form 483 is dated June 29, 2016.
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.