Overview
- 16 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-14.
At a glance
Inspections
16
Form 483s
10
EIRs
4
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2025 – 14 Mar 2025 | Medical Devices & Rad Health | Clean | |
| 24 Feb 2025 – 7 Mar 2025 | Medical Devices & Rad Health | Clean | |
| 1 Oct 2019 – 25 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Feb 2019 – 21 Feb 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Apr 2018 – 15 May 2018 | Medical Devices & Rad Health | WL | View 483 → |
| 16 Aug 2017 – 29 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Jan 2017 – 17 Feb 2017 | Medical Devices & Rad Health | 483 | On file |
| 5 Apr 2016 – 28 Apr 2016 | Medical Devices & Rad Health | 483 | On file |
| 22 Oct 2014 – 19 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 2 Oct 2013 – 25 Oct 2013 | Medical Devices & Rad Health | Clean | |
| 24 Aug 2012 | Not recorded | Clean | |
| 9 Nov 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Oct 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Dianiris C Ayala, Laiza V Garcia, Monica C Burgos Garcia
25 Oct 2019
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Dianiris C Ayala, Laiza V Garcia, Monica C Burgos Garcia
25 Oct 2019
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Dianiris C Ayala, Laiza V Garcia, Monica C Burgos Garcia
25 Oct 2019
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Dianiris C Ayala, Laiza V Garcia, Monica C Burgos Garcia
Investigators
FDA investigators tied to this site in the record.
Laiza V Garcia5 insp.
Monica C Burgos Garcia3 insp.
Adaliz Santaliz-Cruz3 insp.
Marilyn Santiago3 insp.
Nydia E Colon2 insp.
Wanda J Torres2 insp.
Dianiris C Ayala1 insp.
Annette Melendez1 insp.
Kimberly Lewandowski-Walker1 insp.
Rafael Gonzalez1 insp.
Lisa M Lopez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic Puerto Rico Operations Co.'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