Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-29.
At a glance
Inspections
11
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Nov 2023 | Human Drugs | 483 | View 483 → |
| 6 Nov 2023 – 15 Nov 2023 | Human Drugs | Clean | |
| 6 Aug 2018 – 17 Aug 2018 | Human Drugs | 483 | On file |
| 6 Sep 2016 – 13 Sep 2016 | Human Drugs | 483 | View 483 → |
| 6 May 2015 – 8 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Mar 2014 – 12 May 2014 | Medical Devices & Rad Health | 483 | On file |
| 23 Sep 2013 – 26 Sep 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 May 2011 | Not recorded | 483 | On file |
| 15 Dec 2005 | Not recorded | Clean | |
| 22 Nov 2002 | Not recorded | Clean | |
| 29 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Nov 2023
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Santos E Camara, Ariel Cruz Figueroa
Investigators
FDA investigators tied to this site in the record.
Noreen Muniz3 insp.
Santos E Camara2 insp.
Ariel Cruz Figueroa2 insp.
Laiza V Garcia1 insp.
Miguel A Martinez1 insp.
Rafael Gonzalez1 insp.
German Rivera1 insp.
Karl D Hezel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baxter Healthcare Corporation's 7 Form 483s
Source PDFs, 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