Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-24.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Apr 2026 – 24 Apr 2026 | Biologics | 483 | View 483 → |
| 25 Jul 2022 – 26 Jul 2022 | Biologics | Clean | |
| 26 Nov 2018 – 27 Nov 2018 | Biologics | Clean | |
| 11 May 2017 – 12 May 2017 | Biologics | 483 | View 483 → |
| 13 Apr 2015 – 17 Apr 2015 | Biologics | Clean | |
| 8 May 2013 – 10 May 2013 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 May 2013
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Catherine M Beer
Investigators
FDA investigators tied to this site in the record.
Chanel E Crawford1 insp.
Anthony N Onianwa1 insp.
Marlene L Davis1 insp.
Robert J Veitch1 insp.
Juan R Jimenez Garcia1 insp.
Catherine M Beer1 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 | 2x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(g)(1) | 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
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