Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-02-20.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2026 – 20 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Apr 2023 – 25 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 4 Feb 2020 – 11 Feb 2020 | Medical Devices & Rad Health | Clean | |
| 13 Feb 2017 – 27 Feb 2017 | Medical Devices & Rad Health | Clean | |
| 21 Oct 2014 – 14 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 20 May 2009 | Not recorded | Clean | |
| 30 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Feb 2026
ISO 13485:2016 Clause 7.5.6
Planned results not consistently met during validation of processes
Cited by Monica C Burgos Garcia
20 Feb 2026
ISO 13485:2016 Clause 8.2.5
Suitable methods for monitoring and measuring QMS processes not applied
Cited by Monica C Burgos Garcia
Investigators
FDA investigators tied to this site in the record.
Monica C Burgos Garcia3 insp.
Nydia E Colon1 insp.
Maricelys Mercado1 insp.
Laiza V Garcia1 insp.
Karl D Hezel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.5 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Stryker Puerto Rico, LLC's 1 Form 483
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