Clarus Medical, Lie
Form 483 issued March 10, 2021 · Minneapolis, Minnesota
- Inspection
- Feb 24 – Mar 10, 2021
- Investigator
- Joseph D. Gong
- Observations
- 1
- Pages
- 4
- FEI number
- 1000116142
In short: On March 10, 2021, FDA issued a Form 483 with 1 observation to Clarus Medical, Lie in Minneapolis, Minnesota (FEI 1000116142) after an inspection that ran Feb 24 – Mar 10, 2021. The investigator was Joseph D. Gong. 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
Joseph D. Gong
4 documents · 2017–2021
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Minnesota.
The firmClarus Medical, Lie history
The site's inspection history, in date order.
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 Clarus Medical, Lie?
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 Clarus Medical, Lie?
Joseph D. Gong is named on this Form 483, for the inspection of Feb 24 – Mar 10, 2021. Each investigator has a profile showing what they cite most.
When was Clarus Medical, Lie inspected by FDA?
The inspection ran Feb 24 – Mar 10, 2021, and the Form 483 is dated March 10, 2021.
How do I get the full Form 483 for Clarus Medical, Lie?
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.