Uriel Pharmacy
Form 483 issued March 4, 2025 · East Troy, Wisconsin
- Inspection
- Feb 25 – Mar 4, 2025
- Investigator
- Michele L. Glendenning
- Observations
- 14
- Pages
- 8
- FEI number
- 3003813327
In short: On March 4, 2025, FDA issued a Form 483 with 14 observations to Uriel Pharmacy in East Troy, Wisconsin (FEI 3003813327) after an inspection that ran Feb 25 – Mar 4, 2025. The investigator was Michele L. Glendenning. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 02
The in-process control procedures were deficient in that they did not include an examination of the…
- 03
Add Continuation Page Yih 2 (helt Pevense Michele L. Glendenning, Investigator OF THIS ‘ > igal…
- 04
The evaluation of the stability of homeopathic drug products is not based on the same container-closure…
This inspection in context
Michele L. Glendenning
18 documents · 2018–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Illinois.
The firmUriel Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Uriel Pharmacy?
FDA listed 14 observations on this Form 483, mostly about production, quality system and materials. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Uriel Pharmacy?
Michele L. Glendenning is named on this Form 483, for the inspection of Feb 25 – Mar 4, 2025. Each investigator has a profile showing what they cite most.
When was Uriel Pharmacy inspected by FDA?
The inspection ran Feb 25 – Mar 4, 2025, and the Form 483 is dated March 4, 2025.
How do I get the full Form 483 for Uriel Pharmacy?
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.