Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-30.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jan 2020 – 30 Jan 2020 | Biologics | Clean | |
| 18 Jan 2017 – 20 Jan 2017 | Biologics | Clean | |
| 29 Aug 2016 – 31 Aug 2016 | Biologics | Clean | |
| 16 Feb 2011 | Not recorded | 483 | View 483 → |
| 28 Mar 2008 | Not recorded | 483 | On file |
| 9 Feb 2002 | Not recorded | Clean | |
| 6 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Feb 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Donna D Gallien, Whitney White
16 Feb 2011
21 CFR 606.100(b)(2)
Donor qualifying tests & measurements
Cited by Donna D Gallien, Whitney White
16 Feb 2011
21 CFR 606.170(a)
Adverse Reaction- Reports of Investigations
Cited by Donna D Gallien, Whitney White
Investigators
FDA investigators tied to this site in the record.
Donna D Gallien2 insp.
Christopher J Adams1 insp.
Samantha J Pinizzotto1 insp.
Konsuela Y Glass1 insp.
Whitney White1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Plasma Biological Services' 2 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