Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
22 Jul 2011
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by William A Warnick, Rachel C Harrington, Brooke K Higgins, Ernest Bizjak
22 Jul 2011
21 CFR 211.63
Equipment Design, Size and Location
Cited by William A Warnick, Rachel C Harrington, Brooke K Higgins, Ernest Bizjak
22 Jul 2011
21 CFR 211.67(b)
Written procedures not established/followed
Cited by William A Warnick, Rachel C Harrington, Brooke K Higgins, Ernest Bizjak
22 Jul 2011
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by William A Warnick, Rachel C Harrington, Brooke K Higgins, Ernest Bizjak
Inspected site
BPBora Pharmaceuticals Injectables IncBaltimore, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 observations
The source PDF and 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