Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
29 Oct 2009
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Joey C West, Nebil A Oumer, Brooke K Higgins, Ernest Bizjak
29 Oct 2009
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Joey C West, Nebil A Oumer, Brooke K Higgins, Ernest Bizjak
29 Oct 2009
21 CFR 211.110(b)
In-process materials specifications testing
Cited by Joey C West, Nebil A Oumer, Brooke K Higgins, Ernest Bizjak
29 Oct 2009
21 CFR 211.115(b)
Reprocessing/quality control unit
Cited by Joey C West, Nebil A Oumer, Brooke K Higgins, Ernest Bizjak
29 Oct 2009
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Joey C West, Nebil A Oumer, Brooke K Higgins, Ernest Bizjak
Inspected site
JCJubilant Cadista Pharmaceuticals, Inc.Salisbury, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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