Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
10 Jan 2014
21 CFR 211.80(b)
Handling and Storage to Prevent Contamination
Cited by Michael A Charles, Zachery L Miller, Ashleigh P Wodushek
10 Jan 2014
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michael A Charles, Zachery L Miller, Ashleigh P Wodushek
10 Jan 2014
21 CFR 211.192
Written record of investigation incomplete
Cited by Michael A Charles, Zachery L Miller, Ashleigh P Wodushek
10 Jan 2014
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Michael A Charles, Zachery L Miller, Ashleigh P Wodushek
10 Jan 2014
21 CFR 820.198(c)
Investigation of device failures
Cited by Michael A Charles, Zachery L Miller, Ashleigh P Wodushek
Inspected site
FUFresenius USA Manufacturing, Inc.Ogden, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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