Overview
- 14 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-19.
At a glance
Inspections
14
Form 483s
10
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2024 – 19 Jul 2024 | Human Drugs | 483 | On file |
| 19 Jul 2021 – 30 Jul 2021 | Human Drugs | Clean | |
| 3 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | View 483 → |
| 22 Aug 2016 – 3 Oct 2016 | Human Drugs | 483 | On file |
| 6 Apr 2015 – 1 May 2015 | Human Drugs | 483 | View 483 → |
| 15 Jan 2014 – 11 Feb 2014 | Human Drugs | 483 | View 483 → |
| 16 Sep 2013 – 26 Sep 2013 | Human Drugs | Clean | |
| 13 Mar 2013 – 19 Apr 2013 | Human Drugs | WL | View 483 → |
| 3 Nov 2011 | Not recorded | 483 | View 483 → |
| 27 Apr 2011 | Not recorded | Clean | |
| 26 Aug 2010 | Not recorded | 483 | View 483 → |
| 14 May 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Dec 2018
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
21 Dec 2018
21 CFR 211.194(d)
Laboratory equipment calibration records
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
21 Dec 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
21 Dec 2018
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
21 Dec 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez3 insp.
Noreen Muniz3 insp.
Santos E Camara2 insp.
Dayna I Martinez2 insp.
Amir Alavi1 insp.
Ariel Cruz Figueroa1 insp.
Laurimer Kuilan-Torres1 insp.
Miguel A Martinez1 insp.
Libia M Lugo1 insp.
Jose F Velez1 insp.
German Rivera1 insp.
Laiza V Garcia1 insp.
Karl D Hezel1 insp.
Paul L Bellamy1 insp.
Patric C Klotzbuecher1 insp.
Brenda Rivera1 insp.
Ivis L Negron Torres1 insp.
Ramon A Hernandez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baxter Healthcare Corporation's 10 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