ProMed Pharma, LLC
Form 483 issued October 17, 2023 · Plymouth, Minnesota
- Inspection
- Oct 16 – Oct 17, 2023
- Investigator
- Kevin P. Regan
- Observations
- 1
- Pages
- 2
- FEI number
- 3003335547
In short: On October 17, 2023, FDA issued a Form 483 with 1 observation to ProMed Pharma, LLC in Plymouth, Minnesota (FEI 3003335547) after an inspection that ran Oct 16 – Oct 17, 2023. The investigator was Kevin P. Regan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180(e)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not followed for evaluations done at least annually and including provisions for a…
This inspection in context
Kevin P. Regan
7 documents · 2021–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Minnesota.
The firmProMed Pharma, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180(e)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ProMed Pharma, LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected ProMed Pharma, LLC?
Kevin P. Regan is named on this Form 483, for the inspection of Oct 16 – Oct 17, 2023. Each investigator has a profile showing what they cite most.
When was ProMed Pharma, LLC inspected by FDA?
The inspection ran Oct 16 – Oct 17, 2023, and the Form 483 is dated October 17, 2023.
How do I get the full Form 483 for ProMed Pharma, LLC?
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.