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 3003079019.
Observations1
Issue DateMarch 15, 2024
Status1 Related Warning Letter
Related Inspections3
Establishment Details
Firm
Kobayashi America Manufacturing, LLC
Location
Dalton, Georgia, United States
FEI Number
3003079019
Product Type
Drugs
Issue Date
March 15, 2024
Country
United States
Inspection History, 2022 to 2024
VAI2
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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