Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-10-19.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Oct 2018 – 19 Oct 2018 | Foods & Cosmetics | 483 | View 483 → |
| 20 Oct 2015 – 21 Oct 2015 | Foods & Cosmetics | Clean | |
| 8 Jul 2013 – 10 Jul 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 |
| 21 CFR 111.570(b)(2)(ii)(F) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(C) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Power Organics Inc.'s 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat