University of Iowa Pharmaceuticals
Form 483 issued June 22, 2023 · Iowa City, Iowa
- Inspection
- Jun 22, 2023
- Investigators
- Conner N. Mann· Torrey M. Ward
- Observations
- 4
- Pages
- 5
- FEI number
- 1918751
In short: On June 22, 2023, FDA issued a Form 483 with 4 observations to University of Iowa Pharmaceuticals in Iowa City, Iowa (FEI 1918751) after an inspection that ran Jun 22, 2023. The investigators were Conner N. Mann and Torrey M. Ward. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Specific identification tests are not conducted on components that have been accepted based on the…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Written procedures describing the handling of complaints do not include provisions for a determination as to…
This inspection in context
Conner N. Mann
7 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Kansas.
The firmUniversity of Iowa Pharmaceuticals history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University of Iowa Pharmaceuticals?
FDA listed 4 observations on this Form 483, mostly about production, materials and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected University of Iowa Pharmaceuticals?
Conner N. Mann and Torrey M. Ward are named on this Form 483, for the inspection of Jun 22, 2023. Each investigator has a profile showing what they cite most.
When was University of Iowa Pharmaceuticals inspected by FDA?
The inspection ran Jun 22, 2023, and the Form 483 is dated June 22, 2023.
How do I get the full Form 483 for University of Iowa Pharmaceuticals?
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.