Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
11 Apr 2023
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Heather A Mccauley, Matt D Suedkamp
11 Apr 2023
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Heather A Mccauley, Matt D Suedkamp
11 Apr 2023
21 CFR 111.70(b)(3)
Specifications - contamination limits
Cited by Heather A Mccauley, Matt D Suedkamp
11 Apr 2023
21 CFR 111.70(b)(3)
Specifications - contamination limits
Cited by Heather A Mccauley, Matt D Suedkamp
11 Apr 2023
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Heather A Mccauley, 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(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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