FDA Inspection
Denver Solutions, LLC DBA Leiters HealthDenver Solutions, LLC DBA Leiters Health – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Denver Solutions, LLC DBA Leiters Health, with an inspection on February 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · d16f51c4-a1c3-443f-a67a-a59f0c8905c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042272
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Denver Solutions, LLC DBA Leiters Health
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2025 | Not classified | Denver District Office | Drug Quality Assurance |
| April 5, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 7, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Denver Solutions, LLC DBA Leiters Health
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.