Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-01-22.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2019 | Medical Devices & Rad Health | Clean | |
| 16 May 2018 – 1 Aug 2018 | Medical Devices & Rad Health | WL | View 483 → |
| 22 Aug 2016 – 1 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 20 Feb 2013 – 25 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 15 Dec 2009 | Not recorded | Clean | |
| 27 Oct 2009 | Not recorded | Clean | |
| 31 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Lack of or inadequate procedures
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Statistical techniques - Lack of or inadequate procedures
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Production processes
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Environmental control Lack of or inadequate procedures
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Contamination control, Lack of or inadequate procedures
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Investigators
FDA investigators tied to this site in the record.
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(a) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Becton Dickinson Medical Systems' 1 Form 483
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