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 3008539245.
Observations6
Issue DateDecember 01, 2017
Status1 Related Warning Letter
Related Inspections2
Establishment Details
Firm
Spectra Therapy, LLC.
Location
Port Huron, Michigan, United States
FEI Number
3008539245
Product Type
Devices
Issue Date
December 01, 2017
Country
United States
Inspection History, 2017 to 2024
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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