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.
25 Oct 2012
21 CFR 211.22(a)
Approve or reject components, products
Cited by Shafiq Ahadi, Steven D Kehoe
25 Oct 2012
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Shafiq Ahadi, Steven D Kehoe
25 Oct 2012
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Shafiq Ahadi, Steven D Kehoe
25 Oct 2012
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Shafiq Ahadi, Steven D Kehoe
25 Oct 2012
21 CFR 211.165(a)
Testing and release for distribution
Cited by Shafiq Ahadi, Steven D Kehoe
Inspected site
BIBuckeye International IncMaryland Heights, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | 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