Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-24.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 24 Mar 2026 | Biologics | 483 | View 483 → |
| 29 Jul 2019 – 31 Jul 2019 | Biologics | Clean | |
| 4 Mar 2013 – 12 Mar 2013 | Biologics | 483 | View 483 → |
| 28 Jul 2011 | Not recorded | Clean | |
| 11 Feb 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Mar 2026
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Scott T Ballard, Celeta S Coves, Emily S Mcgann
24 Mar 2026
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Scott T Ballard, Celeta S Coves, Emily S Mcgann
24 Mar 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Scott T Ballard, Celeta S Coves, Emily S Mcgann
24 Mar 2026
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Scott T Ballard, Celeta S Coves, Emily S Mcgann
24 Mar 2026
21 CFR 211.188(b)(12)
Documentation of Batch Investigations
Cited by Scott T Ballard, Celeta S Coves, Emily S Mcgann
Investigators
FDA investigators tied to this site in the record.
Gene D Arcy3 insp.
Scott T Ballard1 insp.
Celeta S Coves1 insp.
Emily S Mcgann1 insp.
Laurissa S Flowers1 insp.
Andy B Lee1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.190(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind StemCyte, Inc'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