Zencore Biologics Co., Ltd. – FDA Inspection, Sep 6, 2023

Record Details

This FDA Inspection record concerns Zencore Biologics Co., Ltd., with an inspection on September 6, 2023, issued by the Office of Inspections and Investigations.

Company: Zencore Biologics Co., Ltd.
Inspection Date: September 6, 2023
Office: Office of Inspections and Investigations
Person: Marcellinus D. Dordunoo (FDA Associated Person)

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ID · 6a48123c-7d16-4f2f-91ea-f192abe77368

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1218137
FDA center: Human Drugs
Outcome: Form 483 issued

FDA Citations

21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance

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FDA Inspection

Zencore Biologics Co., Ltd.September 6, 2023