FDA Inspection
Denver Solutions, LLC DBA Leiters HealthDenver Solutions, LLC DBA Leiters Health – FDA Inspection, Dec 11, 2025
Record Details
This FDA Inspection record concerns Denver Solutions, LLC DBA Leiters Health, with an inspection on December 11, 2025, issued by the Denver District Office, covering human drugs.
- Inspection Date
- December 11, 2025
- Product Type
- Human Drugs
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ID · 66c420ab-f198-4005-82c3-4cbd1b06b340
Inspection Facts
- Inspection number
- 1294820
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Denver Solutions, LLC DBA Leiters Health
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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