Denver Solutions, LLC dba Leiter's Health
Form 483 issued December 11, 2025 · Englewood, Colorado
- Inspection
- Nov 13 – Dec 11, 2025
- Investigator
- Margaret M. Annes
- Observations
- 7
- Pages
- 7
- FEI number
- 3013438582
In short: On December 11, 2025, FDA issued a Form 483 with 7 observations to Denver Solutions, LLC dba Leiter's Health in Englewood, Colorado (FEI 3013438582) after an inspection that ran Nov 13 – Dec 11, 2025. The investigator was Margaret M. Annes. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Equipment used iri the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmDenver Solutions, LLC dba Leiter's Health history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Denver Solutions, LLC dba Leiter's Health?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Denver Solutions, LLC dba Leiter's Health?
Margaret M. Annes is named on this Form 483, for the inspection of Nov 13 – Dec 11, 2025. Each investigator has a profile showing what they cite most.
When was Denver Solutions, LLC dba Leiter's Health inspected by FDA?
The inspection ran Nov 13 – Dec 11, 2025, and the Form 483 is dated December 11, 2025.
How do I get the full Form 483 for Denver Solutions, LLC dba Leiter's Health?
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