Denver Solutions, LLC dba Leiter's Health
FDA inspection history across 2 sites, 2018 to 2026
- 5
- Form 483s
- 1
- Untitled letter
Every document, by year
- Untitled letter
- Form 483
2018: one Form 483; 2019: one Form 483; 2021: one Form 483; 2024: one Form 483; 2025: one Form 483; 2026: one untitled letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–21Three Form 483s, at Englewood, Colorado and Eng l ewo o d, Colorado.
- 2024–26Two Form 483s and one untitled letter, at Englewood, Colorado.
- 2024The longest 483 on file: 7 observations over 11 pages at Englewood, Colorado.
Cited most
Across all Denver Solutions, LLC dba Leiter's Health observations on file
- 21 CFR 211.42(c)(10)(i)Design and construction features8
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.192Production record review3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.160(b)General requirements2
The complete Denver Solutions, LLC dba Leiter's Health file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Englewood, Colorado
Four Form 483s and one untitled letter · 2018 to 2026 · 19 observations
Latest: Untitled letter, Jun 8, 2026 →Eng l ewo o d, Colorado
One Form 483 · 2021 · 7 observations
Latest: Form 483, Oct 7, 2021 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-06-08 | Untitled letter Untitled letter | Englewood, Colorado | — | $99 |
| 2025-12-11 | 483 Form 483 | Englewood, Colorado | 7 | $99 |
| 2024-04-05 | 483 Form 483 | Englewood, Colorado | 7 | $99 |
| 2021-10-07 | 483 Form 483 | Eng l ewo o d, Colorado | 7 | $99 |
| 2019-07-18 | 483 Form 483 | Englewood, Colorado | 1 | $99 |
| 2018-02-23 | 483 Form 483 | Englewood, Colorado | 4 | $99 |
Investigators on these documents
Alan P. Kurtzberg (1)Margaret M. Annes (1)Michael A. Charles (1)Nicholas L. Hunt (1)Taichun Qin (1)Zachery L. Miller (1)
FEI number 3013438582 · most recent document Jun 8, 2026
About Denver Solutions, LLC dba Leiter's Health
How many FDA Form 483s has Denver Solutions, LLC dba Leiter's Health received?
FDA Intel has 5 Form 483s on file for Denver Solutions, LLC dba Leiter's Health; the most recent is dated Dec 11, 2025.
When was Denver Solutions, LLC dba Leiter's Health last inspected by FDA?
The most recent FDA inspection document on file for Denver Solutions, LLC dba Leiter's Health is a Form 483 dated Dec 11, 2025, for the site in Englewood, Colorado.
What did FDA cite at Denver Solutions, LLC dba Leiter's Health?
The regulations cited most in the observations on file for Denver Solutions, LLC dba Leiter's Health are 21 CFR 211.42(c)(10)(i) (Design and construction features), 8 times; 21 CFR 211.113(b) (Control of microbiological contamination), 3 times; 21 CFR 211.192 (Production record review), 3 times.
Has Denver Solutions, LLC dba Leiter's Health received an FDA untitled letter?
Yes. FDA Intel has 1 FDA untitled letter on file for Denver Solutions, LLC dba Leiter's Health; the most recent is dated Jun 8, 2026. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.