Overview
- 4 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Sep 2015
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by James M Odonnell
17 Sep 2015
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by James M Odonnell
17 Sep 2015
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by James M Odonnell
17 Sep 2015
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by James M Odonnell
Inspected site
BSBionen S.A.S.Florence, Italy
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 2x |
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, 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