ProMed Pharma, LLC
Form 483 issued February 21, 2024 · Plymouth, Minnesota
- Inspection
- Feb 14 – Feb 21, 2024
- Investigator
- Albert L. Nguyen
- Observations
- 1
- Pages
- 3
- FEI number
- 3003335547
In short: On February 21, 2024, FDA issued a Form 483 with 1 observation to ProMed Pharma, LLC in Plymouth, Minnesota (FEI 3003335547) after an inspection that ran Feb 14 – Feb 21, 2024. The investigator was Albert L. Nguyen. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
This inspection in context
Albert L. Nguyen
4 documents · 2020–2024
Cites 820.70(a) (production and process controls) 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 820.100(a)
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 cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected ProMed Pharma, LLC?
Albert L. Nguyen is named on this Form 483, for the inspection of Feb 14 – Feb 21, 2024. Each investigator has a profile showing what they cite most.
When was ProMed Pharma, LLC inspected by FDA?
The inspection ran Feb 14 – Feb 21, 2024, and the Form 483 is dated February 21, 2024.
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.