DeChoker LLC
FDA inspection history in Wheat Ridge, Colorado, 2021
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2021: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One warning letter and one Form 483, at Wheat Ridge, Colorado.
Cited most
Across all DeChoker observations on file
- 21 CFR 820.30(g)Design controls2
- 21 CFR 820.70(a)Production and process controls2
- 21 CFR 8201
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete DeChoker 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
Wheat Ridge, Colorado
One warning letter and one Form 483 · 2021 · 11 observations
Latest: Warning letter, May 10, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-05-10 | Warning letter Warning letter | Wheat Ridge, Colorado | — | $99 |
| 2021-02-26 | 483 Form 483 | Wheat Ridge, Colorado | 11 | $99 |
Investigators on these documents
FEI number 3011422544 · most recent document May 10, 2021
About DeChoker LLC
How many FDA Form 483s has DeChoker LLC received?
FDA Intel has 1 Form 483 on file for DeChoker LLC; the most recent is dated Feb 26, 2021.
When was DeChoker LLC last inspected by FDA?
The most recent FDA inspection document on file for DeChoker LLC is a Form 483 dated Feb 26, 2021, for the site in Wheat Ridge, Colorado.
What did FDA cite at DeChoker LLC?
The regulations cited most in the observations on file for DeChoker LLC are 21 CFR 820.30(g) (Design controls), 2 times; 21 CFR 820.70(a) (Production and process controls), 2 times; 21 CFR 820, 1 time.
Has DeChoker LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for DeChoker LLC; the most recent is dated May 10, 2021.