Magna Pharmaceuticals, Inc.
Form 483 issued October 29, 2021 · Louisville, Kentucky
- Inspection
- Oct 21 – Oct 29, 2021
- Investigator
- Shannon A. Gregory
- Observations
- 1
- Pages
- 3
- FEI number
- 3007457368
In short: On October 29, 2021, FDA issued a Form 483 with 1 observation to Magna Pharmaceuticals, Inc. in Louisville, Kentucky (FEI 3007457368) after an inspection that ran Oct 21 – Oct 29, 2021. The investigator was Shannon A. Gregory. 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
Shannon A. Gregory
5 documents · 2015–2022
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Kentucky.
The firmMagna Pharmaceuticals, Inc. 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 Magna Pharmaceuticals, Inc.?
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 Magna Pharmaceuticals, Inc.?
Shannon A. Gregory is named on this Form 483, for the inspection of Oct 21 – Oct 29, 2021. Each investigator has a profile showing what they cite most.
When was Magna Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Oct 21 – Oct 29, 2021, and the Form 483 is dated October 29, 2021.
How do I get the full Form 483 for Magna Pharmaceuticals, Inc.?
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.