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.
7 Feb 2012
21 CFR 212.20(d)
Determination need for investigation
Cited by Barbara J Breithaupt, James S Stuart, Lawrence Y Lee
7 Feb 2012
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Barbara J Breithaupt, James S Stuart, Lawrence Y Lee
7 Feb 2012
21 CFR 212.30(b)
Not capable of repeatable valid results
Cited by Barbara J Breithaupt, James S Stuart, Lawrence Y Lee
7 Feb 2012
21 CFR 212.50(b)
Master Production and Control Records
Cited by Barbara J Breithaupt, James S Stuart, Lawrence Y Lee
7 Feb 2012
21 CFR 212.50(b)(7)
Complete instructions, procedures, specs
Cited by Barbara J Breithaupt, James S Stuart, Lawrence Y Lee
Inspected site
PSPETNET Solutions IncKent, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(d) | 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