Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-07-29.
At a glance
Inspections
5
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jul 2021 – 29 Jul 2021 | Medical Devices & Rad Health | Clean | |
| 8 Aug 2016 – 18 Aug 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Mar 2012 | Not recorded | 483 | View 483 → |
| 6 Jun 2008 | Not recorded | 483 | On file |
| 17 Jun 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Aug 2016
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Adaliz Santaliz-Cruz
13 Mar 2012
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Marilyn Santiago
Investigators
FDA investigators tied to this site in the record.
Monica C Burgos Garcia1 insp.
Adaliz Santaliz-Cruz1 insp.
Marilyn Santiago1 insp.
Wanda J Torres1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Becton Dickinson Caribe LTD's 3 Form 483s
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