Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-03-01.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2019 – 1 Mar 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jul 2018 – 30 Jul 2018 | Medical Devices & Rad Health | Clean | |
| 5 Aug 2013 – 14 Aug 2013 | Medical Devices & Rad Health | Clean | |
| 27 Aug 2010 | Not recorded | Clean | |
| 16 Sep 2005 | Not recorded | Clean | |
| 25 Aug 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Mar 2019
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Melanie W Pishnery, Yung W Chan
1 Mar 2019
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Melanie W Pishnery, Yung W Chan
1 Mar 2019
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Melanie W Pishnery, Yung W Chan
Investigators
FDA investigators tied to this site in the record.
Ernest H Blackwood2 insp.
Melanie W Pishnery1 insp.
Yung W Chan1 insp.
Miaja Umaedi1 insp.
Dellarese L Herbert1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind BD Life Sciences, Preanalytical Solutions' 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