Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
24 Nov 2015
21 CFR 120.11(a)(1)
Verification activities - minimum
Cited by Kibily D Dembele, Karen M Labounty
24 Nov 2015
21 CFR 120.11(a)(1)(iv)
Verification - CCP, CA record review
Cited by Kibily D Dembele, Karen M Labounty
24 Nov 2015
21 CFR 120.11(a)(1)(iv)(C)
Calibration, testing - record review adequacy
Cited by Kibily D Dembele, Karen M Labounty
24 Nov 2015
21 CFR 120.7(d)
Hazard analysis - evaluation of effect on safety (S)
Cited by Kibily D Dembele, Karen M Labounty
Inspected site
CSCitrus Systems IncHopkins, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 120.11(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(a)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(a)(1)(iv)(C) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.7(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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