Quadric BioMed, LLC
Form 483 issued December 16, 2024 · Colorado Springs, Colorado
- Inspection
- Dec 12 – Dec 16, 2024
- Investigator
- Matthew M. Vernon
- Observations
- 4
- Pages
- 5
- FEI number
- 3025467473
In short: On December 16, 2024, FDA issued a Form 483 with 4 observations to Quadric BioMed, LLC in Colorado Springs, Colorado (FEI 3025467473) after an inspection that ran Dec 12 – Dec 16, 2024. The investigator was Matthew M. Vernon. Most observations concern management controls and production & process controls.
At a glance
3 of 4 observations on this 483 concern management controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
Procedures for quality audits have…
- 03
Procedures for management review have…
- 04
Procedures for training and identifying training needs 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 firmQuadric BioMed, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quadric BioMed, LLC?
FDA listed 4 observations on this Form 483, mostly about management controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Quadric BioMed, LLC?
Matthew M. Vernon is named on this Form 483, for the inspection of Dec 12 – Dec 16, 2024. Each investigator has a profile showing what they cite most.
When was Quadric BioMed, LLC inspected by FDA?
The inspection ran Dec 12 – Dec 16, 2024, and the Form 483 is dated December 16, 2024.
How do I get the full Form 483 for Quadric BioMed, 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.