Overview
- 16 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Aug 2018
21 CFR 111.120(c)
QC operations - material review, disposition decision
Cited by Matt D Suedkamp
22 Aug 2018
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Matt D Suedkamp
Inspected site
PPPI Pharma IncCampton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.120(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(l)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.325(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 16 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