FDA Inspection 860960 — Protech Professional Products, Inc.

Protech Professional Products, Inc. — FEI 1000137415

The FDA completed an inspection of Protech Professional Products, Inc. on Dec 13, 2013 in Boynton Beach, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI)
End Date
Dec 13, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Boynton Beach, FL (United States)

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures