Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-28.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2024 – 28 Feb 2024 | Biologics | Clean | |
| 8 Sep 2022 – 13 Sep 2022 | Biologics | Clean | |
| 4 Jun 2019 – 10 Jun 2019 | Biologics | Clean | |
| 20 Jun 2017 – 26 Jun 2017 | Biologics | Clean | |
| 27 Aug 2015 – 2 Sep 2015 | Biologics | 483 | On file |
| 2 May 2013 – 8 May 2013 | Biologics | 483 | View 483 → |
| 7 Feb 2011 | Not recorded | Clean | |
| 3 Oct 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 May 2013
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Christina N Maurino
Investigators
FDA investigators tied to this site in the record.
Sarah M Forney2 insp.
Jennifer L Custodio2 insp.
Amy A Johnson1 insp.
Christina N Maurino1 insp.
Deborah B Nixon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 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