Denver Solutions, LLC dba Leiter's Health
Form 483 issued October 7, 2021 · Eng l ewo o d, Colorado
- Inspection
- Sep 23 – Oct 7, 2021
- Investigators
- Alan P. Kurtzberg· Michael A. Charles
- Observations
- 7
- Pages
- 7
- FEI number
- 3013438582
In short: On October 7, 2021, FDA issued a Form 483 with 7 observations to Denver Solutions, LLC dba Leiter's Health in Eng l ewo o d, Colorado (FEI 3013438582) after an inspection that ran Sep 23 – Oct 7, 2021. The investigators were Alan P. Kurtzberg and Michael A. Charles. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Deviations from written production and process control…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.192
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 facilities & equipment, production 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?
Alan P. Kurtzberg and Michael A. Charles are named on this Form 483, for the inspection of Sep 23 – Oct 7, 2021. 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 Sep 23 – Oct 7, 2021, and the Form 483 is dated October 7, 2021.
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.