Denver Solutions, LLC dba Leiter's Health
Form 483 issued July 18, 2019 · Englewood, Colorado
- Inspection
- Jul 1 – Jul 18, 2019
- Investigator
- Zachery L. Miller
- Observations
- 1
- Pages
- 3
- FEI number
- 3013438582
In short: On July 18, 2019, FDA issued a Form 483 with 1 observation to Denver Solutions, LLC dba Leiter's Health in Englewood, Colorado (FEI 3013438582) after an inspection that ran Jul 1 – Jul 18, 2019. The investigator was Zachery L. Miller. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient in that walls are not smooth and/or hard surfaces…
This inspection in context
Zachery L. Miller
17 documents · 2011–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
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 211.42(c)(10)(i)
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 1 observation on this Form 483, mostly about facilities & equipment. 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?
Zachery L. Miller is named on this Form 483, for the inspection of Jul 1 – Jul 18, 2019. 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 Jul 1 – Jul 18, 2019, and the Form 483 is dated July 18, 2019.
How do I get the full Form 483 for Denver Solutions, LLC dba Leiter's Health?
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.