Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-26.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Jan 2024 – 26 Jan 2024 | Biologics | 483 | View 483 → |
| 4 Dec 2018 – 10 Dec 2018 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jan 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Susan M Jackson, Laurel A Beer
26 Jan 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Susan M Jackson, Laurel A Beer
26 Jan 2024
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Susan M Jackson, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sanofi Winthrop Industrie'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