Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
6 Dec 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Theresa Kirkham, Constance Y Fears
6 Dec 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Theresa Kirkham, Constance Y Fears
6 Dec 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Theresa Kirkham, Constance Y Fears
6 Dec 2016
21 CFR 211.94(b)
Protection from external factors
Cited by Theresa Kirkham, Constance Y Fears
Inspected site
SSSintetica S.A.Mendrisio, Switzerland
Inspection team
CYConstance Y Fears
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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