Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-04-16.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2026 – 16 Apr 2026 | Human Drugs | 483 | View 483 → |
| 10 Apr 2025 | Biologics | Clean | |
| 19 Apr 2018 – 20 Apr 2018 | Biologics | Clean | |
| 12 Feb 2015 | Biologics | Clean | |
| 18 Jul 2013 – 19 Jul 2013 | Biologics | Clean | |
| 15 Sep 2011 | Not recorded | Clean | |
| 9 Feb 2010 | Not recorded | Clean | |
| 25 Jan 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Apr 2026
FDCA 501(a)(2)(A)
Failure to clean and disinfect/sterilize equipment, ISO 5 area
Cited by Nicholas L Hunt
16 Apr 2026
FDCA 501(a)(2)(A)
Lack of disinfection, equipment/supplies from lower to higher quality air
Cited by Nicholas L Hunt
16 Apr 2026
FDCA 501(a)(2)(A)
Lack of/infrequent, measurement of room pressure differentials
Cited by Nicholas L Hunt
Investigators
FDA investigators tied to this site in the record.
Natasha N Mccants4 insp.
Nicholas L Hunt1 insp.
Fabian N Chaparro-Rodriguez1 insp.
Erika M Wilkerson1 insp.
Kenneth R Merritt1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 8x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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