Overview
- 18 public-safe observations are available for this inspection.
- 9 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.
4 Apr 2018
21 CFR 111.210(g)
Packaging description, representative label
Cited by Sonia R Peterson, Celia L Hutchinstein
4 Apr 2018
21 CFR 111.210(h)(2)
Master manufacturing record - sampling, tests, examinations
Cited by Sonia R Peterson, Celia L Hutchinstein
4 Apr 2018
21 CFR 111.210(h)(3)
Master manufacturing record - specific actions; quality
Cited by Sonia R Peterson, Celia L Hutchinstein
4 Apr 2018
21 CFR 111.210(h)(3)
Master manufacturing record - specific actions; quality
Cited by Sonia R Peterson, Celia L Hutchinstein
Inspected site
INIndependent Nutrition, Inc.Eugene, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(a)(3)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(d)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 18 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