Overview
- 6 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.
21 Jul 2017
21 CFR 211.165(a)
Testing and release for distribution
Cited by Nicholas L Hunt, Santiago Gallardo Johnson
21 Jul 2017
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Nicholas L Hunt, Santiago Gallardo Johnson
21 Jul 2017
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Nicholas L Hunt, Santiago Gallardo Johnson
21 Jul 2017
21 CFR 211.63
Equipment Design, Size and Location
Cited by Nicholas L Hunt, Santiago Gallardo Johnson
21 Jul 2017
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Nicholas L Hunt, Santiago Gallardo Johnson
Inspected site
GCGenlabs CorporationChino, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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