Halo Innovations Inc
Form 483 issued March 6, 2019 · Hopkins, Minnesota
- Inspection
- Oct 17, 2018 – Mar 6, 2019
- Investigator
- Ralph W. Jerkdal
- Observations
- 1
- Pages
- 3
- FEI number
- 3006606837
In short: On March 6, 2019, FDA issued a Form 483 with 1 observation to Halo Innovations Inc in Hopkins, Minnesota (FEI 3006606837) after an inspection that ran Oct 17, 2018 – Mar 6, 2019. The investigator was Ralph W. Jerkdal. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(f) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design verification have…
This inspection in context
Ralph W. Jerkdal
6 documents · 2004–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Minnesota.
The firmHalo Innovations Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Halo Innovations Inc?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Halo Innovations Inc?
Ralph W. Jerkdal is named on this Form 483, for the inspection of Oct 17, 2018 – Mar 6, 2019. Each investigator has a profile showing what they cite most.
When was Halo Innovations Inc inspected by FDA?
The inspection ran Oct 17, 2018 – Mar 6, 2019, and the Form 483 is dated March 6, 2019.
How do I get the full Form 483 for Halo Innovations 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.