Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
8 Apr 2014
21 CFR 211.130(d)
Examination of packaging and labeling
Cited by Meisha R Sampson, Meisha R Waters
8 Apr 2014
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Meisha R Sampson, Meisha R Waters
8 Apr 2014
21 CFR 211.186(a)
Signature and checking of records -- 2 persons
Cited by Meisha R Sampson, Meisha R Waters
Inspected site
PPPharmakon Pharmaceuticals, Inc.Noblesville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF and 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