Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-12-04.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2025 | Biologics | Clean | |
| 5 Apr 2023 | Biologics | Clean | |
| 11 Mar 2020 | Biologics | Clean | |
| 5 Dec 2017 – 6 Dec 2017 | Biologics | Clean | |
| 23 Sep 2014 | Biologics | Clean | |
| 2 Mar 2012 | Not recorded | Clean | |
| 25 Mar 2010 | Not recorded | 483 | View 483 → |
| 18 Jan 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Mar 2010
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Gayle S Lawson, Linda M Hoover
25 Mar 2010
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Gayle S Lawson, Linda M Hoover
25 Mar 2010
21 CFR 1271.55(b)(2)
Listing and interpretation of CD tests performed
Cited by Gayle S Lawson, Linda M Hoover
Investigators
FDA investigators tied to this site in the record.
Kish Bolden2 insp.
Emily A Walters1 insp.
Nikisha M Bolden1 insp.
Erika M Wilkerson1 insp.
Kimberly A Dux1 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 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(2) | 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