Company
United StatesHepQuant, LLC, Denver, CO – FDA Inspections
Inspection records and compliance data for HepQuant, LLC in Denver, Colorado. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected November 01, 2024.
Company Profile
This profile covers HepQuant, LLC based in Denver, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 8, 2021. Last inspected November 1, 2024.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate2 inspections
- DMR - not or inadequately maintained2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 1, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1253122 |
| May 24, 2023 | OAI | Medical Devices & Rad Health | 1206220 |
| May 4, 2023 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1209316 |
| June 8, 2021 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1143974 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
HepQuant, LLC
FEI Number
3011510745
Address
8110 E Union Ave Ste 750, Denver, Colorado 80237, United States
Country
United States
ID: a38e8405-e12a-4b75-aaca-d79de3f58f73