University of Iowa Pharmaceuticals
Form 483 issued May 4, 2018 · Iowa City, Iowa
- Inspection
- Apr 30 – May 4, 2018
- Investigator
- Rita K. Kabaso
- Observations
- 4
- Pages
- 5
- FEI number
- 1918751
In short: On May 4, 2018, FDA issued a Form 483 with 4 observations to University of Iowa Pharmaceuticals in Iowa City, Iowa (FEI 1918751) after an inspection that ran Apr 30 – May 4, 2018. The investigator was Rita K. Kabaso. Most observations concern materials and laboratory controls.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 04
Complaint procedures are deficient in that they do not include provisions that allow for the review…
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.87
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 materials, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected University of Iowa Pharmaceuticals?
Rita K. Kabaso is named on this Form 483, for the inspection of Apr 30 – May 4, 2018. Each investigator has a profile showing what they cite most.
When was University of Iowa Pharmaceuticals inspected by FDA?
The inspection ran Apr 30 – May 4, 2018, and the Form 483 is dated May 4, 2018.
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.