FDA Inspection
18HHS LLC18HHS LLC – FDA Inspection, Jun 1, 2026
Record Details
This FDA Inspection record concerns 18HHS LLC, with an inspection on June 1, 2026, issued by the Dallas District Office, covering biologics.
- Office
- Dallas District Office
- People
- Ashleigh M. Robertson (Issuing Officer)
- Elyshia Q. Danaher (Issuing Officer)
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ID · 1dd60029-e0c1-4dce-a07e-657ca07e4e21
Inspection Facts
- Inspection number
- 1319908
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.65(b)(2)Prominently labeled (limited use)
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.90(c)(1)Autologous use only--labeling
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