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 1720129.
Observations7
Issue DateMarch 01, 2024
Status2 Related Warning Letters
Related Inspections6
Establishment Details
Firm
Optikem International, Inc.
Location
Denver, Colorado, United States
FEI Number
1720129
Product Type
Devices
Issue Date
March 01, 2024
Country
United States
Inspection History, 2010 to 2024
VAI4
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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