WalkMed Infusion, LLC
Form 483 issued June 11, 2015 · Englewood, Colorado
- Inspection
- May 18 – Jun 11, 2015
- Investigator
- Janet Pulver
- Observations
- 10
- Pages
- 9
- FEI number
- 3000204189
In short: On June 11, 2015, FDA issued a Form 483 with 10 observations to WalkMed Infusion, LLC in Englewood, Colorado (FEI 3000204189) after an inspection that ran May 18 – Jun 11, 2015. The investigator was Janet Pulver. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 8 of 10 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device to meet any of its specifications were…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Janet Pulver
10 documents · 2014–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmWalkMed Infusion, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WalkMed Infusion, LLC?
FDA listed 10 observations on this Form 483, mostly about cAPA, 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 WalkMed Infusion, LLC?
Janet Pulver is named on this Form 483, for the inspection of May 18 – Jun 11, 2015. Each investigator has a profile showing what they cite most.
When was WalkMed Infusion, LLC inspected by FDA?
The inspection ran May 18 – Jun 11, 2015, and the Form 483 is dated June 11, 2015.
How do I get the full Form 483 for WalkMed Infusion, LLC?
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.