Overview
- 12 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-14.
At a glance
Inspections
12
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2025 – 14 Apr 2025 | Biologics | 483 | View 483 → |
| 12 Apr 2023 – 13 Apr 2023 | Biologics | Clean | |
| 23 Jul 2019 – 24 Jul 2019 | Biologics | Clean | |
| 24 Aug 2016 – 26 Aug 2016 | Biologics | Clean | |
| 16 Jul 2014 – 21 Jul 2014 | Biologics | Clean | |
| 9 Nov 2011 | Not recorded | 483 | View 483 → |
| 30 Sep 2011 | Not recorded | Clean | |
| 1 Apr 2008 | Not recorded | 483 | On file |
| 6 Apr 2006 | Not recorded | Clean | |
| 18 May 2004 | Not recorded | Clean | |
| 7 Apr 2003 | Not recorded | Clean | |
| 24 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Apr 2025
21 CFR 606.100(b)(14)
QC procedures for supplies and reagents
Cited by Fabian N Chaparro-Rodriguez
14 Apr 2025
21 CFR 606.65(c)
Testing of representative samples of reagent lots
Cited by Fabian N Chaparro-Rodriguez
14 Apr 2025
21 CFR 606.65(e)
Following manufacturer's instructions
Cited by Fabian N Chaparro-Rodriguez
Investigators
FDA investigators tied to this site in the record.
Natasha N Mccants3 insp.
Fabian N Chaparro-Rodriguez1 insp.
Johnathan M Crayton1 insp.
Juanelma H Palmer1 insp.
Barbara D Wright1 insp.
Myla T Collins1 insp.
Danielle M Maddox1 insp.
Brian S Lynch1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(14) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.4(f) | 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