Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-17.
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 |
|---|---|---|---|
| 11 Jan 2023 – 17 Jan 2023 | Biologics | Clean | |
| 5 Jun 2018 – 6 Jun 2018 | Biologics | Clean | |
| 25 May 2016 – 31 May 2016 | Biologics | Clean | |
| 27 Aug 2013 – 30 Aug 2013 | Biologics | Clean | |
| 20 Aug 2010 | Not recorded | Clean | |
| 27 Jul 2009 | Not recorded | WL | View 483 → |
| 15 Sep 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jul 2009
21 CFR 1271.50(a)
Responsible person to determine, document
Cited by Sherri J Jackson, Catherine V Quinlan
27 Jul 2009
21 CFR 1271.50(b)(2)
Donor testing not negative for CD agents
Cited by Sherri J Jackson, Catherine V Quinlan
27 Jul 2009
21 CFR 1271.55(d)(2)
Accurate, indelible, legible
Cited by Sherri J Jackson, Catherine V Quinlan
27 Jul 2009
21 CFR 1271.60(a)
Completion of eligibility determination
Cited by Sherri J Jackson, Catherine V Quinlan
27 Jul 2009
21 CFR 1271.80(d)(1)
Reactive tests--not determined ineligible
Cited by Sherri J Jackson, Catherine V Quinlan
Investigators
FDA investigators tied to this site in the record.
Matthew J Gretkierewicz4 insp.
Sherri J Jackson2 insp.
Catherine V Quinlan2 insp.
Victoria A Murray1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(d)(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