Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
7 Sep 2012
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Zachary L Stamm, Erika V Butler, Kimberley A Hoefen
7 Sep 2012
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Zachary L Stamm, Erika V Butler, Kimberley A Hoefen
7 Sep 2012
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Zachary L Stamm, Erika V Butler, Kimberley A Hoefen
7 Sep 2012
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Zachary L Stamm, Erika V Butler, Kimberley A Hoefen
7 Sep 2012
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Zachary L Stamm, Erika V Butler, Kimberley A Hoefen
Inspected site
TITolmar IncFort Collins, 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 211.110(a) | 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 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | 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 10 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