Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-02-02.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Jan 2023 – 2 Feb 2023 | Human Drugs | Clean | |
| 3 Dec 2018 – 4 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 19 Jun 2013 – 21 Jun 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jun 2013
21 CFR 211.25(a)
GMP Training Frequency
Cited by Michele Perry-Williams, Freddy Ortiz Colon
21 Jun 2013
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Michele Perry-Williams, Freddy Ortiz Colon
21 Jun 2013
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Michele Perry-Williams, Freddy Ortiz Colon
21 Jun 2013
21 CFR 211.192
Written record of investigation incomplete
Cited by Michele Perry-Williams, Freddy Ortiz Colon
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 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | 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 Baxter R & D Europe SPRL's 1 Form 483
Verbatim observations 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