Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-06-01.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 May 2026 – 1 Jun 2026 | Biologics | 483 | View 483 → |
| 1 Nov 2022 – 4 Nov 2022 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Jun 2026
21 CFR 1271.65(b)(2)
Prominently labeled (limited use)
Cited by Elyshia Q Danaher, Ashleigh M Robertson
1 Jun 2026
21 CFR 1271.90(c)
Eligibility not required--warning labels
Cited by Elyshia Q Danaher, Ashleigh M Robertson
1 Jun 2026
21 CFR 1271.90(c)(1)
Autologous use only--labeling
Cited by Elyshia Q Danaher, Ashleigh M Robertson
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 1271.65(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind 18HHS LLC'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