Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-07-26.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2024 – 26 Jul 2024 | Medical Devices & Rad Health | 483 | On file |
| 22 Aug 2022 – 26 Aug 2022 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jul 2024
21 CFR 820.250(b)
Sampling methods - Lack of or inadequate procedures
Cited by Monica C Burgos Garcia
26 Jul 2024
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Monica C Burgos Garcia
26 Jul 2024
21 CFR 820.80(a)
Lack of or inadequate procedures - Acceptance activities
Cited by Monica C Burgos Garcia
Investigators
FDA investigators tied to this site in the record.
Monica C Burgos Garcia2 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 | 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 |
Full site report
Get the verbatim findings behind Terumo 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