FDA Inspection
Denver Solutions, LLC DBA Leiters HealthDenver Solutions, LLC DBA Leiters Health – FDA Inspection, Apr 5, 2024
Record Details
This FDA Inspection record concerns Denver Solutions, LLC DBA Leiters Health, with an inspection on April 5, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 29f61503-d2ea-4bf3-b34a-e92be48494a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235828
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- FD&C Act 503B(a)(10)(B)Drug product container, fails to include
- FD&C Act 503B(a)(10)(A)Drug product labels, fails to include
- 21 CFR 211.67(b)Written procedures not established/followed
- FDCA 503B(a)(10)(A)Drug product labels, fails to include
- FDCA 503B(a)(10)(B)Drug product container, fails to include
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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 |
| 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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