Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-11-28.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Nov 2017 – 28 Nov 2017 | Medical Devices & Rad Health | Clean | |
| 26 Apr 2016 – 12 May 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 May 2015 – 19 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Nov 2010 | Not recorded | 483 | On file |
| 13 Jun 2008 | Not recorded | 483 | On file |
| 2 Jun 2004 | Not recorded | Clean | |
| 5 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 May 2016
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Mary R Hole, Jacqueline M Cleary
12 May 2016
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Mary R Hole, Jacqueline M Cleary
12 May 2016
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Mary R Hole, Jacqueline M Cleary
12 May 2016
21 CFR 820.198(b)
Review and evaluation for investigation
Cited by Mary R Hole, Jacqueline M Cleary
12 May 2016
21 CFR 820.198(b)
Review and evaluation for investigation
Cited by Mary R Hole, Jacqueline M Cleary
Investigators
FDA investigators tied to this site in the record.
Mary R Hole2 insp.
Mark E Chan1 insp.
Jacqueline M Cleary1 insp.
Francis J Eng1 insp.
Christine M Parmentier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1040.10(g)(10) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Becton, Dickinson and Company, BD Biosciences' 4 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