Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
25 Aug 2011
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Matthew R Dionne, Kimberley A Hoefen, Matthew J Hansen
25 Aug 2011
21 CFR 211.63
Equipment Design, Size and Location
Cited by Matthew R Dionne, Kimberley A Hoefen, Matthew J Hansen
25 Aug 2011
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Matthew R Dionne, Kimberley A Hoefen, Matthew J Hansen
25 Aug 2011
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Matthew R Dionne, Kimberley A Hoefen, Matthew J Hansen
25 Aug 2011
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Matthew R Dionne, Kimberley A Hoefen, Matthew J Hansen
Inspected site
UPUSL Pharma Inc. dba Upsher-Smith Laboratories, LLCDenver, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 observations
Every observation in full, 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