Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
18 Mar 2016
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles, Roger F Zabinski, Xiaohui Shen, Zhihao Pete Qiu
18 Mar 2016
21 CFR 211.42(b)
Product flow through building is inadequate
Cited by Michael A Charles, Roger F Zabinski, Xiaohui Shen, Zhihao Pete Qiu
18 Mar 2016
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Michael A Charles, Roger F Zabinski, Xiaohui Shen, Zhihao Pete Qiu
18 Mar 2016
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Michael A Charles, Roger F Zabinski, Xiaohui Shen, Zhihao Pete Qiu
18 Mar 2016
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Michael A Charles, Roger F Zabinski, Xiaohui Shen, Zhihao Pete Qiu
Inspected site
SDSimtra Deutschland GmbHHalle (Westf.), Germany
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | 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 211.46(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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