Overview
- 6 public-safe observations are available for this inspection.
- 4 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.
17 Nov 2009
21 CFR 211.67(b)(4)
Cleaning SOPs/equipment identification
Cited by Meredith L Sheridan, Addam S Reynolds
17 Nov 2009
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Meredith L Sheridan, Addam S Reynolds
17 Nov 2009
21 CFR 211.115(a)
Reprocessing procedures not written or followed
Cited by Meredith L Sheridan, Addam S Reynolds
17 Nov 2009
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Meredith L Sheridan, Addam S Reynolds
17 Nov 2009
21 CFR 211.192
Quality control unit review of records
Cited by Meredith L Sheridan, Addam S Reynolds
Inspected site
BLBentley Laboratories LLCEdison, 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 | 3x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | 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