Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-01.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Aug 2023 – 1 Sep 2023 | Human Drugs | 483 | On file |
| 7 Jun 2023 – 9 Jun 2023 | Human Drugs | Clean | |
| 17 Nov 2022 – 22 Nov 2022 | Human Drugs | 483 | View 483 → |
| 23 Oct 2017 – 27 Oct 2017 | Human Drugs | Clean | |
| 5 Mar 2014 – 7 Mar 2014 | Human Drugs | 483 | On file |
| 8 Apr 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Nov 2022
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Guerlain Ulysse, Xiaokuang Lai
22 Nov 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Guerlain Ulysse, Xiaokuang Lai
Investigators
FDA investigators tied to this site in the record.
Kara A Scheibner1 insp.
Camerson E Moore1 insp.
Guerlain Ulysse1 insp.
Xiaokuang Lai1 insp.
Zhongren Wu1 insp.
Jose A Lopez Rubet1 insp.
Thomas W Nojek1 insp.
Denise M Digiulio1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Solvias AG's 3 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat