Yangtze River Pharmaceutical (Group) Co., Ltd. – FDA Inspection, Jun 28, 2024

Record Details

This FDA Inspection record concerns Yangtze River Pharmaceutical (Group) Co., Ltd., with an inspection on June 28, 2024, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Yangtze River Pharmaceutical (Group) Co., Ltd.
Inspection Date: June 28, 2024
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Marcellinus D. Dordunoo (FDA Associated Person)

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ID · da4b7721-b28a-4ad2-a29b-b86ab8d79664

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1245074
FDA center: Human Drugs
Project area: Generic Drug Evaluation
Outcome: Form 483 issued

FDA Citations

21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 211.113(b)Validation lacking for sterile drug products
21 CFR 211.42(c)(10)(iv)Environmental Monitoring System

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FDA Inspection

Yangtze River Pharmaceutical (Group) Co., Ltd.June 28, 2024