Company
United StatesBiorep Technologies, Inc., Miami Lakes, FL – FDA Inspections
Inspection records and compliance data for Biorep Technologies, Inc. in Miami Lakes, Florida. 3 FDA inspections on record, 1 Form 483, last inspected April 26, 2024.
Company Profile
This profile covers Biorep Technologies, Inc. based in Miami Lakes, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 6, 2016. Last inspected April 26, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 26, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1239221 |
| February 5, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1043579 |
| December 6, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 995537 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biorep Technologies, Inc.
FEI Number
3005593675
Address
15804 Nw 57th Ave, Miami Lakes, Florida 33014, United States
Country
United States
ID: 2a7c1340-6e3a-4d7d-933f-feda95c8fe22