Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-08.
At a glance
Inspections
3
Form 483s
2
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Feb 2024 | Biologics | Clean | |
| 12 Apr 2021 – 20 Apr 2021 | Biologics | 483 | On file |
| 9 Apr 2020 – 20 Apr 2020 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Apr 2020
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Marcellinus D Dordunoo
20 Apr 2020
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Marcellinus D Dordunoo
20 Apr 2020
21 CFR 211.68(b)
Computer control of master formula records
Cited by Marcellinus D Dordunoo
Investigators
FDA investigators tied to this site in the record.
Jeremy L Wally2 insp.
Priscilla M Pastrana1 insp.
Cody D Rickman1 insp.
Debra M Emerson1 insp.
Marcellinus D Dordunoo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Syngene USA Inc.'s 2 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