Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
11 Feb 2009
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
11 Feb 2009
21 CFR 211.68(b)
Written record not kept of program and validation data
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
11 Feb 2009
21 CFR 211.101(c)
Weighing/measuring/subdividing supervision
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
11 Feb 2009
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
11 Feb 2009
21 CFR 211.192
Written record of investigation incomplete
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
Inspected site
FIFagron, IncSaint Paul, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.101(c) | 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 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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