Overview
- 9 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Sep 2019
21 CFR 111.35(b)(3)
Documentation - instruments, controls; calibrations
Cited by Felicia M Orlando
5 Sep 2019
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Felicia M Orlando
Inspected site
OSOne Solution, LLC dba Complete Packaging & ManufacturingOrem, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(C) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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