Overview
- 6 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.
14 May 2012
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Lauren L Vajo, Lisa M Bellows
14 May 2012
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Lauren L Vajo, Lisa M Bellows
14 May 2012
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Lauren L Vajo, Lisa M Bellows
14 May 2012
21 CFR 211.194(a)(5)
Calculations performed are in the records
Cited by Lauren L Vajo, Lisa M Bellows
Inspected site
BLBiochem Laboratory, Inc.Lyndhurst, 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 | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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