Overview
- 4 public-safe observations are available for this inspection.
- 2 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.
5 Sep 2018
21 CFR 211.122(a)
Written procedures not followed
Cited by Sean R Marcsisin, Jonathan G Matrisciano, Margaret M Sands
5 Sep 2018
21 CFR 211.122(a)
Written procedures not followed
Cited by Sean R Marcsisin, Jonathan G Matrisciano, Margaret M Sands
5 Sep 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sean R Marcsisin, Jonathan G Matrisciano, Margaret M Sands
5 Sep 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sean R Marcsisin, Jonathan G Matrisciano, Margaret M Sands
Inspected site
PPharmasolStoughton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 4 observations
The full inspection record, as Atlas holds it, 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