FDA Inspection

Wanbang BiopharmaceuticalsSeptember 8, 2023

FDA Inspection 1219529 - Wanbang Biopharmaceuticals - September 08, 2023

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Record Details

This FDA Inspection record concerns Wanbang Biopharmaceuticals, with an inspection on September 8, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Wanbang Biopharmaceuticals
Inspection Date: September 8, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Patty P. Kaewussdangkul (FDA Associated Person)

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ID · eb0257cf-af2b-441d-871e-6d531adbefbb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1219529
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 211.194(a)(5)Testing Calculations

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