FDA Inspection 1173360 — DS REP B.V. LLC

DS REP B.V. LLC — FEI 2647456

The FDA completed an inspection of DS REP B.V. LLC on Jun 16, 2022 in Las Piedras, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Jun 16, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Las Piedras, PR (United States)

Citations

IDCFRDescription
383721 CFR 820.25(b)Training records
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures