Minnesota MedTec, Inc.
Form 483 issued December 11, 2019 · Maple Grove, Minnesota
- Inspection
- Dec 3 – Dec 11, 2019
- Investigators
- Benjamin W. Anderson· Tyler R. Courtney
- Observations
- 1
- Pages
- 6
- FEI number
- 3003007911
In short: On December 11, 2019, FDA issued a Form 483 with 1 observation to Minnesota MedTec, Inc. in Maple Grove, Minnesota (FEI 3003007911) after an inspection that ran Dec 3 – Dec 11, 2019. The investigators were Benjamin W. Anderson and Tyler R. Courtney. Most observations concern management controls; the most-cited regulation is 21 CFR 820.25 (personnel).
At a glance
1 of 1 observations on this 483 concern management controls.
Most cited: 21 CFR 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for training and identifying training needs have…
This inspection in context
Benjamin W. Anderson
3 documents · 2018–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Minnesota.
The firmMinnesota MedTec, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.25(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Minnesota MedTec, Inc.?
FDA listed 1 observation on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.25 (personnel). The opening words of each observation are shown on this page.
Who inspected Minnesota MedTec, Inc.?
Benjamin W. Anderson and Tyler R. Courtney are named on this Form 483, for the inspection of Dec 3 – Dec 11, 2019. Each investigator has a profile showing what they cite most.
When was Minnesota MedTec, Inc. inspected by FDA?
The inspection ran Dec 3 – Dec 11, 2019, and the Form 483 is dated December 11, 2019.
How do I get the full Form 483 for Minnesota MedTec, 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.