Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Apr 2014
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Jennifer A Robinson, Mizanne E Lewis, Michael H Tollon
1 Apr 2014
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Jennifer A Robinson, Mizanne E Lewis, Michael H Tollon
1 Apr 2014
21 CFR 211.166(b)
Adequate number of batches on stability
Cited by Jennifer A Robinson, Mizanne E Lewis, Michael H Tollon
1 Apr 2014
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer A Robinson, Mizanne E Lewis, Michael H Tollon
1 Apr 2014
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Jennifer A Robinson, Mizanne E Lewis, Michael H Tollon
Inspected site
BBBelleview Biosciences LLCBrooksville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | 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 8 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