Overview
- 12 public-safe observations are available for this inspection.
- 11 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.
8 Apr 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Brian R Yaun, Carrie L Doupnik, Brooke K Higgins, Ernest Bizjak
8 Apr 2010
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Brian R Yaun, Carrie L Doupnik, Brooke K Higgins, Ernest Bizjak
8 Apr 2010
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Brian R Yaun, Carrie L Doupnik, Brooke K Higgins, Ernest Bizjak
8 Apr 2010
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Brian R Yaun, Carrie L Doupnik, Brooke K Higgins, Ernest Bizjak
8 Apr 2010
21 CFR 211.165(e)
Test methods
Cited by Brian R Yaun, Carrie L Doupnik, Brooke K Higgins, Ernest Bizjak
Inspected site
BLBarr Laboratories Inc.Forest, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 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