Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
8 Sep 2023
21 CFR 211.194(a)(2)
Suitability of testing methods verified
Cited by Roger F Zabinski, Laurel A Beer
8 Sep 2023
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Roger F Zabinski, Laurel A Beer
8 Sep 2023
21 CFR 211.68(b)
Backup data not assured as exact and complete
Cited by Roger F Zabinski, Laurel A Beer
Inspected site
IBIDT Biologika GmbHDessau-Rosslau, Germany
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.1 | 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, 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