Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-05-09.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Apr 2013 – 9 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Mar 2011 | Not recorded | 483 | View 483 → |
| 13 Sep 2007 | Not recorded | Clean | |
| 15 Jun 2006 | Not recorded | Clean | |
| 20 May 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 May 2013
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Marilyn Santiago
9 May 2013
21 CFR 820.75(c)
Documentation - review in response to changes or deviations
Cited by Marilyn Santiago
31 Mar 2011
21 CFR 806.20(b)(4)
Justification for not reporting
Cited by Marilyn Santiago, Shelly A Rios Laluz
31 Mar 2011
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Marilyn Santiago, Shelly A Rios Laluz
Investigators
FDA investigators tied to this site in the record.
Marilyn Santiago2 insp.
Shelly A Rios Laluz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Becton Dickinson Caribe Ltd's 2 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