Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-04-27.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Apr 2026 – 27 Apr 2026 | Biologics | Clean | |
| 1 Aug 2023 – 2 Aug 2023 | Biologics | Clean | |
| 9 Jul 2018 – 10 Jul 2018 | Biologics | Clean | |
| 14 May 2013 – 16 May 2013 | Biologics | 483 | View 483 → |
| 28 Apr 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2013
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Gene D Arcy, Linda Thai, Ademola O Daramola
Investigators
FDA investigators tied to this site in the record.
Karen J Bak2 insp.
Sunitha K Rajaram1 insp.
Gene D Arcy1 insp.
Linda Thai1 insp.
Ademola O Daramola1 insp.
Robert S Sweeton1 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 |
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