Overview
- 12 public-safe observations are available for this inspection.
- 6 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.
1 Aug 2017
21 CFR 111.103
Written procedures - quality control operations
Cited by Sundy V Sedwick, Sundy Ven
1 Aug 2017
21 CFR 111.103
Written procedures - quality control operations
Cited by Sundy V Sedwick, Sundy Ven
1 Aug 2017
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Sundy V Sedwick, Sundy Ven
1 Aug 2017
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Sundy V Sedwick, Sundy Ven
1 Aug 2017
21 CFR 111.75(a)(2)
Component - confirm identity; specifications met
Cited by Sundy V Sedwick, Sundy Ven
Inspected site
GSGrand Stone CorporationOrange, 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 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(d)(1) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 12 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