FDA Inspection
HepQuant, LLCHepQuant, LLC – FDA Inspection, May 24, 2023
Record Details
This FDA Inspection record concerns HepQuant, LLC, with an inspection on May 24, 2023, issued by the Denver District Office.
- Company
- HepQuant, LLC
- Inspection Date
- May 24, 2023
View Company Profile
ID · 2e6beb7c-759c-4564-93f2-af3ab9231de6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1206220
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HepQuant, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2024 | Not classified | Denver District Office | Compliance: Medical Devices |
| May 4, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 8, 2021 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for HepQuant, LLC
- FDA Inspection 1253122 - 2024-11-01
- FDA Inspection 1209316 - 2023-05-04
- FDA Inspection 1143974 - 2021-06-08
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