Overview
- 10 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-01-05.
At a glance
Inspections
10
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jan 2024 – 5 Jan 2024 | Biologics | Clean | |
| 3 Dec 2019 – 5 Dec 2019 | Biologics | Clean | |
| 17 Apr 2018 – 3 May 2018 | Biologics | 483 | View 483 → |
| 3 May 2016 – 16 May 2016 | Biologics | Clean | |
| 30 Oct 2013 – 5 Nov 2013 | Biologics | Clean | |
| 23 May 2012 | Not recorded | Clean | |
| 8 Apr 2010 | Not recorded | Clean | |
| 23 Jan 2008 | Not recorded | Clean | |
| 12 Jun 2003 | Not recorded | Clean | |
| 1 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 May 2018
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Lorayne A Mcguinness
3 May 2018
21 CFR 606.100(b)(5)
Accurate measurement of quantity of blood
Cited by Lorayne A Mcguinness
Investigators
FDA investigators tied to this site in the record.
Lorayne A Mcguinness3 insp.
Elizabeth B Griffin2 insp.
Jonah S Ufferfilge1 insp.
Sherry M Nisson1 insp.
Alice C Silva1 insp.
Courtney N Long1 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)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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