Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-06.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 May 2024 – 6 Jun 2024 | Biologics | Clean | |
| 21 Sep 2021 – 23 Sep 2021 | Biologics | Clean | |
| 14 Jan 2014 – 12 Feb 2014 | Biologics | 483 | View 483 → |
| 4 Feb 2013 | Not recorded | 483 | View 483 → |
| 27 Apr 2010 | Not recorded | 483 | View 483 → |
| 31 Aug 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Feb 2014
21 CFR 1271.160(b)(6)
Deviations--evaluation, cause, corrective action
Cited by Nancy L Neiger
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.150(c)(1)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.265(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.65(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.220(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.250(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(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 1271.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Stembanc Inc's 4 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