Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-22.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Apr 2026 – 22 Apr 2026 | Biologics | Clean | |
| 20 Oct 2023 – 25 Oct 2023 | Biologics | 483 | View 483 → |
| 24 Feb 2020 – 25 Feb 2020 | Biologics | 483 | View 483 → |
| 6 Jun 2017 – 7 Jun 2017 | Biologics | Clean | |
| 20 Aug 2015 – 4 Sep 2015 | Biologics | Clean | |
| 20 Aug 2015 – 27 Aug 2015 | Biologics | Clean | |
| 10 May 2012 | Not recorded | 483 | View 483 → |
| 13 Nov 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Oct 2023
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Lesley Mae P Lutao
25 Feb 2020
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Lewis K Antwi, Leeterry Moore
Investigators
FDA investigators tied to this site in the record.
Brentley S Collins2 insp.
Zoey A Trombley1 insp.
Lesley Mae P Lutao1 insp.
Lewis K Antwi1 insp.
Leeterry Moore1 insp.
Adam J Taylor1 insp.
Kathleen S Tormey1 insp.
Amanda S Zorn1 insp.
Clotia C Abbey Mensah1 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 | 3x |
| 21 CFR 1271.55(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.150(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(b)(1) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 Form 483s
Source PDFs, 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