Overview
- 12 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Oct 2016
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Chiaochun J Wang, Matthew B Casale, Benjamin J Dastoli, Brian D Rogers
21 Oct 2016
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Chiaochun J Wang, Matthew B Casale, Benjamin J Dastoli, Brian D Rogers
21 Oct 2016
21 CFR 211.110(b)
In-process materials specifications
Cited by Chiaochun J Wang, Matthew B Casale, Benjamin J Dastoli, Brian D Rogers
21 Oct 2016
21 CFR 211.110(b)
In-process materials specifications
Cited by Chiaochun J Wang, Matthew B Casale, Benjamin J Dastoli, Brian D Rogers
21 Oct 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Chiaochun J Wang, Matthew B Casale, Benjamin J Dastoli, Brian D Rogers
Inspected site
HPHikma Pharmaceuticals USA INC.Columbus, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | 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