Denver Solutions, LLC dba Leiter's Health
Form 483 issued April 5, 2024 · Englewood, Colorado
- Inspection
- Mar 20 – Apr 5, 2024
- Investigator
- Taichun Qin
- Observations
- 7
- Pages
- 11
- FEI number
- 3013438582
In short: On April 5, 2024, 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 Mar 20 – Apr 5, 2024. The investigator was Taichun Qin. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 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 are not established…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
The written stability testing…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Denver Solutions, LLC dba Leiter's Health?
Taichun Qin is named on this Form 483, for the inspection of Mar 20 – Apr 5, 2024. 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 Mar 20 – Apr 5, 2024, and the Form 483 is dated April 5, 2024.
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.