Overview
- 52 public-safe observations are available for this inspection.
- 26 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.
6 Oct 2016
21 CFR 111.113(a)(2)
QC master manufacturing record; material review, disposition
Cited by Helen J Hamaoka
6 Oct 2016
21 CFR 111.210(a)
Master manufacturing record - dietary ingredients
Cited by Helen J Hamaoka
Inspected site
GCGeneritech CorporationFresno, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.35(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.113(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(f) | 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)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.25(a) | 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(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.73 | 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)(B) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.95(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.95(b)(4) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 52 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