Overview
- 19 public-safe observations are available for this inspection.
- 18 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
13 Jan 2011
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Zachary A Bogorad, Ademola O Daramola, Vashti E Bocker
13 Jan 2011
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Zachary A Bogorad, Ademola O Daramola, Vashti E Bocker
13 Jan 2011
21 CFR 111.70(c)(1)
In-process identity, purity, strength, composition
Cited by Zachary A Bogorad, Ademola O Daramola, Vashti E Bocker
13 Jan 2011
21 CFR 111.70(c)(1)
Specifications - in-process contamination limits
Cited by Zachary A Bogorad, Ademola O Daramola, Vashti E Bocker
13 Jan 2011
21 CFR 111.73
Specifications met - identity, purity, strength, composition
Cited by Zachary A Bogorad, Ademola O Daramola, Vashti E Bocker
Inspected site
OFOld Fashioned Natural Products IncSanta Ana, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 19 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