Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
12 Mar 2012
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Ivan E Reyes, April L Young
12 Mar 2012
21 CFR 111.103
Written procedures - quality control operations
Cited by Ivan E Reyes, April L Young
12 Mar 2012
21 CFR 111.105(d)
Quality control - basis; tests, examinations
Cited by Ivan E Reyes, April L Young
12 Mar 2012
21 CFR 111.415
Fill, assemble, package, label - master record
Cited by Ivan E Reyes, April L Young
Inspected site
PUPharmacist's Ultimate Health Corp.Saint Paul, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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