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 3011301103.
Observations2
Issue DateNovember 12, 2021
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
Opus KSD, Inc.
Location
Pembroke, Massachusetts, United States
FEI Number
3011301103
Product Type
Devices
Issue Date
November 12, 2021
Country
United States
Inspection History, 2018 to 2026
NAI1
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.