FDA Inspection
HepQuant, LLCHepQuant, LLC – FDA Inspection, Nov 1, 2024
Record Details
This FDA Inspection record concerns HepQuant, LLC, with an inspection on November 1, 2024, issued by the Denver District Office, covering medical devices & rad health.
View Company Profile
ID · 048f31fb-1786-496b-96c6-2c21fe6dc60a
Inspection Facts
- Inspection number
- 1253122
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HepQuant, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2023 | OAI | Denver District Office | |
| 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 1206220 - 2023-05-24
- FDA Inspection 1209316 - 2023-05-04
- FDA Inspection 1143974 - 2021-06-08
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.