Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
30 Jun 2011
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Matthew R Dionne, Caroline H Le, Tamara L Setzer
30 Jun 2011
21 CFR 211.25(a)
GMP Training Frequency
Cited by Matthew R Dionne, Caroline H Le, Tamara L Setzer
30 Jun 2011
21 CFR 211.42(c)(10)(iii)
Air Supply
Cited by Matthew R Dionne, Caroline H Le, Tamara L Setzer
30 Jun 2011
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Matthew R Dionne, Caroline H Le, Tamara L Setzer
30 Jun 2011
21 CFR 211.84(d)(3)
Certificates of Testing (Containers, Closures)
Cited by Matthew R Dionne, Caroline H Le, Tamara L Setzer
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 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | 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 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(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 211.84(d)(3) | 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 11 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