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.
1 Jul 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Marvin D Jones, Patricia D Stahnke
1 Jul 2014
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Marvin D Jones, Patricia D Stahnke
1 Jul 2014
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Marvin D Jones, Patricia D Stahnke
1 Jul 2014
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Marvin D Jones, Patricia D Stahnke
Inspected site
MSMERCK SERONO SPAModugno, Italy
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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