Overview
- 12 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.
16 Dec 2016
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Anastasia M Shields, Junho Pak
16 Dec 2016
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Anastasia M Shields, Junho Pak
16 Dec 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Anastasia M Shields, Junho Pak
16 Dec 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Anastasia M Shields, Junho Pak
16 Dec 2016
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Anastasia M Shields, Junho Pak
Inspected site
GHGC Hanford Manufacturing CompanySyracuse, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 12 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