Exer Labs, Inc
FDA inspection history in Denver, Colorado, 2024 to 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2024–25One Form 483 and one warning letter, at Denver, Colorado.
Cited most
Across all Exer Labs observations on file
- 21 CFR 820.20(b)(3)Management responsibility2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.170(a)Installation1
- 21 CFR 820.198(a)Complaint files1
The complete Exer Labs 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
Denver, Colorado
One warning letter and one Form 483 · 2024 to 2025 · 10 observations
Latest: Warning letter, Feb 10, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-10 | Warning letter Warning letter | Denver, Colorado | — | $99 |
| 2024-10-24 | 483 Form 483 | Denver, Colorado | 10 | $99 |
Investigators on these documents
FEI number 3020929899 · most recent document Feb 10, 2025
About Exer Labs, Inc
How many FDA Form 483s has Exer Labs, Inc received?
FDA Intel has 1 Form 483 on file for Exer Labs, Inc; the most recent is dated Oct 24, 2024.
When was Exer Labs, Inc last inspected by FDA?
The most recent FDA inspection document on file for Exer Labs, Inc is a Form 483 dated Oct 24, 2024, for the site in Denver, Colorado.
What did FDA cite at Exer Labs, Inc?
The regulations cited most in the observations on file for Exer Labs, Inc are 21 CFR 820.20(b)(3) (Management responsibility), 2 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Exer Labs, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Exer Labs, Inc; the most recent is dated Feb 10, 2025.