Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3015602723.
Observations12
Issue DateJanuary 24, 2024
Status1 Related Warning Letter
Related Inspections3
Establishment Details
Firm
Med Pen Concepts, LLC
Location
Woburn, Massachusetts, United States
FEI Number
3015602723
Product Type
Devices
Issue Date
January 24, 2024
Country
United States
Inspection History, 2022 to 2024
VAI1
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.