Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Oct 2021
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Michael A Charles, Alan P Kurtzberg
7 Oct 2021
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Michael A Charles, Alan P Kurtzberg
7 Oct 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michael A Charles, Alan P Kurtzberg
7 Oct 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Michael A Charles, Alan P Kurtzberg
Inspected site
DSDenver Solutions, LLCEnglewood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere