Denver Solutions, LLC dba Leiter's Health
Form 483 issued February 23, 2018 · Englewood, Colorado
- Inspection
- Feb 12 – Feb 23, 2018
- Investigator
- Nicholas L. Hunt
- Observations
- 4
- Pages
- 3
- FEI number
- 3013438582
In short: On February 23, 2018, FDA issued a Form 483 with 4 observations to Denver Solutions, LLC dba Leiter's Health in Englewood, Colorado (FEI 3013438582) after an inspection that ran Feb 12 – Feb 23, 2018. The investigator was Nicholas L. Hunt. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Dmg products failing to meet established quality control…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
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 211.165(f)
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 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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?
Nicholas L. Hunt is named on this Form 483, for the inspection of Feb 12 – Feb 23, 2018. 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 Feb 12 – Feb 23, 2018, and the Form 483 is dated February 23, 2018.
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.