Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
3 Mar 2015
21 CFR 211.180(e)
Records reviewed annually
Cited by Brian J Ryan, Sundy Ven, Rebecca Rodriguez
3 Mar 2015
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Brian J Ryan, Sundy Ven, Rebecca Rodriguez
3 Mar 2015
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Brian J Ryan, Sundy Ven, Rebecca Rodriguez
3 Mar 2015
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Brian J Ryan, Sundy Ven, Rebecca Rodriguez
3 Mar 2015
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by Brian J Ryan, Sundy Ven, Rebecca Rodriguez
Inspected site
BBB. Braun US Pharmaceutical Manufacturing, LLCIrvine, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.180(e) | 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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | 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 5 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