Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-05-23.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2019 – 23 May 2019 | Biologics | 483 | View 483 → |
| 17 Sep 2018 – 21 Sep 2018 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Sep 2018
21 CFR 1271.260(e)
Storage temperatures recorded, maintained
Cited by Tania Y Hall, Thanh B Tran
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 1271.200(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.260(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.265(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.265(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.350(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Liveyon's 2 Form 483s
Source PDFs 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