Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
27 May 2016
21 CFR 111.560(a)(2)
Product complaint - quality control investigate
Cited by Quynh Strandberg, Edna J Hidalgo
27 May 2016
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Quynh Strandberg, Edna J Hidalgo
27 May 2016
21 CFR 111.210(h)(2)
Master manufacturing record - sampling, tests, examinations
Cited by Quynh Strandberg, Edna J Hidalgo
27 May 2016
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Quynh Strandberg, Edna J Hidalgo
Inspected site
CICustompax, Inc., dba VitaganicFremont, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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