Exer Labs, Inc
Form 483 issued October 24, 2024 · Denver, Colorado
- Inspection
- Oct 17 – Oct 24, 2024
- Investigator
- Matthew M. Vernon
- Observations
- 10
- Pages
- 7
- FEI number
- 3020929899
In short: On October 24, 2024, FDA issued a Form 483 with 10 observations to Exer Labs, Inc in Denver, Colorado (FEI 3020929899) after an inspection that ran Oct 17 – Oct 24, 2024. The investigator was Matthew M. Vernon. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Management controls and capa account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures for collective and preventive action have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 04
Written MDR procedures have not been…
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 firmExer Labs, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Exer Labs, Inc?
FDA listed 10 observations on this Form 483, mostly about management controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Exer Labs, Inc?
Matthew M. Vernon is named on this Form 483, for the inspection of Oct 17 – Oct 24, 2024. Each investigator has a profile showing what they cite most.
When was Exer Labs, Inc inspected by FDA?
The inspection ran Oct 17 – Oct 24, 2024, and the Form 483 is dated October 24, 2024.
How do I get the full Form 483 for Exer Labs, Inc?
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.