Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Jul 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Bryan A Galvez
5 Jul 2019
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Bryan A Galvez
5 Jul 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Bryan A Galvez
Inspected site
ISIvers-Lee SABurgdorf, Switzerland
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 | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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