Vasamed, Inc
Form 483 issued May 16, 2019 · Eden Prairie, Minnesota
- Inspection
- May 13 – May 16, 2019
- Investigators
- Jennifer S. Ness· Marissa S. Steinhagen· Tiffany P. Kelley
- Observations
- 2
- Pages
- 6
- FEI number
- 1000116119
In short: On May 16, 2019, FDA issued a Form 483 with 2 observations to Vasamed, Inc in Eden Prairie, Minnesota (FEI 1000116119) after an inspection that ran May 13 – May 16, 2019. The investigators were Jennifer S. Ness, Marissa S. Steinhagen and Tiffany P. Kelley. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.30(i) (1×) · 820.80(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
Procedures for acceptance of incoming product…
This inspection in context
Jennifer S. Ness
5 documents · 2015–2019
Cites 820.90 (nonconforming product) more than any other section. Most of their documents are for sites in Wisconsin.
The firmVasamed, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vasamed, Inc?
FDA listed 2 observations on this Form 483, mostly about design controls and production & process 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 Vasamed, Inc?
Jennifer S. Ness, Marissa S. Steinhagen and Tiffany P. Kelley are named on this Form 483, for the inspection of May 13 – May 16, 2019. Each investigator has a profile showing what they cite most.
When was Vasamed, Inc inspected by FDA?
The inspection ran May 13 – May 16, 2019, and the Form 483 is dated May 16, 2019.
How do I get the full Form 483 for Vasamed, Inc?
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