Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-04-29.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Apr 2022 – 29 Apr 2022 | Biologics | 483 | View 483 → |
| 2 Aug 2021 – 18 Aug 2021 | Biologics | 483 | View 483 → |
| 22 May 2019 – 23 May 2019 | Biologics | 483 | View 483 → |
| 16 Nov 2016 | Biologics | Clean | |
| 18 Feb 2015 | Biologics | Clean | |
| 2 Apr 2013 | Biologics | Clean | |
| 10 May 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Kathleen B Swat3 insp.
Elmina E Akwo1 insp.
William F Lagud1 insp.
John A Iwen1 insp.
Edward E Lockwood1 insp.
Thuy T Nguyen1 insp.
Daniel Sagardia-Vazquez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.55(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.47(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.60(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.85(d) | Cited across public-safe Form 483 observations | 2x |
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