Company
United StatesDS REP B.V., Las Piedras, PR – FDA Inspections
Inspection records and compliance data for DS REP B.V. in Las Piedras, Puerto Rico. 5 FDA inspections on record, 1 Form 483, last inspected October 17, 2025.
Company Profile
This profile covers DS REP B.V. based in Las Piedras, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 18, 2010. Last inspected October 17, 2025.
Most cited issue areas
- Investigation of device failures2 inspections
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 17, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1288064 |
| June 16, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1173360 |
| March 23, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1046784 |
| March 6, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 821728 |
| March 18, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 652360 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
DS REP B.V.
FEI Number
2647456
Address
Carr #183 Km 19.6, Las Piedras, Puerto Rico 00771, United States
Country
United States
ID: 72eac62e-7ba1-46ff-8139-383dcd7cd6e4