DeChoker LLC
Form 483 issued February 26, 2021 · Wheat Ridge, Colorado
- Inspection
- Feb 17 – Feb 26, 2021
- Investigator
- Christine I. Shaw
- Observations
- 11
- Pages
- 10
- FEI number
- 3011422544
In short: On February 26, 2021, FDA issued a Form 483 with 11 observations to DeChoker LLC in Wheat Ridge, Colorado (FEI 3011422544) after an inspection that ran Feb 17 – Feb 26, 2021. The investigator was Christine I. Shaw. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and capa account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 0221 CFR 820.30(j)21 CFR 820
The design history file does not demonstrate that the design was developed following the requirements…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Risk analysis is…
This inspection in context
Christine I. Shaw
8 documents · 2016–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Colorado.
The firmDeChoker 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 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DeChoker LLC?
FDA listed 11 observations on this Form 483, mostly about production & process controls, cAPA and design 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 DeChoker LLC?
Christine I. Shaw is named on this Form 483, for the inspection of Feb 17 – Feb 26, 2021. Each investigator has a profile showing what they cite most.
When was DeChoker LLC inspected by FDA?
The inspection ran Feb 17 – Feb 26, 2021, and the Form 483 is dated February 26, 2021.
How do I get the full Form 483 for DeChoker LLC?
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