Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
3 Oct 2011
21 CFR 111.35(b)(1)(ii)
Procedures - equipment; calibrating, inspecting, checking
Cited by Maida Henesian, Mark A Chen, Wen-Jun Peng
3 Oct 2011
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Maida Henesian, Mark A Chen, Wen-Jun Peng
3 Oct 2011
21 CFR 111.73
Specifications met - identity, purity, strength, composition
Cited by Maida Henesian, Mark A Chen, Wen-Jun Peng
3 Oct 2011
21 CFR 111.105(d)
Quality control - basis; tests, examinations
Cited by Maida Henesian, Mark A Chen, Wen-Jun Peng
3 Oct 2011
21 CFR 111.117(d)
Quality control operations - equipment functions
Cited by Maida Henesian, Mark A Chen, Wen-Jun Peng
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 111.105(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.117(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | 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