Guangzhou PharmaLab Co., Ltd. – FDA Inspection, Aug 30, 2023

Record Details

This FDA Inspection record concerns Guangzhou PharmaLab Co., Ltd., with an inspection on August 30, 2023, issued by the Office of Inspections and Investigations.

Company: Guangzhou PharmaLab Co., Ltd.
Inspection Date: August 30, 2023
Office: Office of Inspections and Investigations
People: Hung H. Do (Issuing Officer)
Rowena S. Nguyen (Issuing Officer)

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ID · bbd007e9-3faf-47cd-8efd-d46eb63ca88c

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1217730
FDA center: Human Drugs
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.68(b)Computer control of master formula records

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FDA Inspection

Guangzhou PharmaLab Co., Ltd.August 30, 2023