Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-01-23.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2026 | Biologics | Clean | |
| 3 May 2023 – 4 May 2023 | Biologics | Clean | |
| 5 Feb 2020 – 6 Feb 2020 | Biologics | Clean | |
| 8 Nov 2017 – 9 Nov 2017 | Biologics | Clean | |
| 29 Jul 2015 – 30 Jul 2015 | Biologics | Clean | |
| 29 Nov 2011 | Not recorded | Clean | |
| 9 Dec 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Dec 2009
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Gayle S Lawson, Linda M Hoover
Investigators
FDA investigators tied to this site in the record.
Kish Bolden2 insp.
Nikisha M Bolden2 insp.
Erika M Wilkerson2 insp.
Emily A Walters1 insp.
Michele M Falchek1 insp.
Gayle S Lawson1 insp.
Linda M Hoover1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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