Overview
- 22 public-safe observations are available for this inspection.
- 11 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.
19 Oct 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Siobhan A Gallagher, Sondra R Davis
19 Oct 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Siobhan A Gallagher, Sondra R Davis
19 Oct 2018
21 CFR 111.127(d)
QC operations - packaged, labeled; specifications
Cited by Siobhan A Gallagher, Sondra R Davis
19 Oct 2018
21 CFR 111.127(d)
QC operations - packaged, labeled; specifications
Cited by Siobhan A Gallagher, Sondra R Davis
19 Oct 2018
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Siobhan A Gallagher, Sondra R Davis
Inspected site
POPower Organics Inc.Mount Shasta, 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 | 2x |
| 21 CFR 111.127(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 22 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