CD Acquisitions, LLC
Form 483 issued August 22, 2023 · Denver, Colorado
- Inspection
- Aug 15 – Aug 22, 2023
- Investigator
- Matthew M. Vernon
- Observations
- 4
- Pages
- 6
- FEI number
- 3014759854
In short: On August 22, 2023, FDA issued a Form 483 with 4 observations to CD Acquisitions, LLC in Denver, Colorado (FEI 3014759854) after an inspection that ran Aug 15 – Aug 22, 2023. The investigator was Matthew M. Vernon. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
Management controls and capa account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for management review have…
- 04
Procedures for quality audits have…
This inspection in context
Matthew M. Vernon
6 documents · 2020–2026
Cites 820.20(b)(3) (management responsibility) more than any other section. Most of their documents are for sites in Colorado.
The firmCD Acquisitions, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CD Acquisitions, LLC?
FDA listed 4 observations on this Form 483, mostly about management controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected CD Acquisitions, LLC?
Matthew M. Vernon is named on this Form 483, for the inspection of Aug 15 – Aug 22, 2023. Each investigator has a profile showing what they cite most.
When was CD Acquisitions, LLC inspected by FDA?
The inspection ran Aug 15 – Aug 22, 2023, and the Form 483 is dated August 22, 2023.
How do I get the full Form 483 for CD Acquisitions, 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.