WalkMed Infusion, LLC
FDA inspection history across 2 sites, 2015
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2015: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One warning letter and one Form 483, at Centennial, Colorado and Englewood, Colorado.
Cited most
Across all WalkMed Infusion observations on file
- 21 CFR 820.30(c)Design controls4
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.160(a)Distribution1
- 21 CFR 820.198(c)Complaint files1
The complete WalkMed Infusion file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Centennial, Colorado
One warning letter · 2015
Latest: Warning letter, Nov 2, 2015 →Englewood, Colorado
One Form 483 · 2015 · 10 observations
Latest: Form 483, Jun 11, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-11-02 | Warning letter Warning letter | Centennial, Colorado | — | $99 |
| 2015-06-11 | 483 Form 483 | Englewood, Colorado | 10 | $99 |
Investigators on these documents
FEI number 3000204189 · most recent document Nov 2, 2015
About WalkMed Infusion, LLC
How many FDA Form 483s has WalkMed Infusion, LLC received?
FDA Intel has 1 Form 483 on file for WalkMed Infusion, LLC; the most recent is dated Jun 11, 2015.
When was WalkMed Infusion, LLC last inspected by FDA?
The most recent FDA inspection document on file for WalkMed Infusion, LLC is a Form 483 dated Jun 11, 2015, for the site in Englewood, Colorado.
What did FDA cite at WalkMed Infusion, LLC?
The regulations cited most in the observations on file for WalkMed Infusion, LLC are 21 CFR 820.30(c) (Design controls), 4 times; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has WalkMed Infusion, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for WalkMed Infusion, LLC; the most recent is dated Nov 2, 2015.