FDA Inspection 1231008 — Kobayashi America Manufacturing, LLC

Kobayashi America Manufacturing, LLC — FEI 3003079019

The FDA completed an inspection of Kobayashi America Manufacturing, LLC on Mar 15, 2024 in Dalton, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Mar 15, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dalton, GA (United States)

Citations

IDCFRDescription
176721 CFR 211.137(a)Expiration date lacking

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