Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Nov 2015
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Edmund F Mrak, Russell J Glapion
Inspected site
MSMerck Serono SAAubonne, Switzerland
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 1 observation
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