Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)August 8, 2023

FDA 483 - Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) - August 08, 2023

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Record Details

An FDA inspection of Hybio Pharmaceutical Co., Ltd.'s Pingshan Factory, a sterile drug manufacturer, revealed significant deficiencies in aseptic processing and equipment cleaning. Observations included inadequate sterility testing, poor aseptic techniques by operators, and improper storage of tools, leading to potential microbiological contamination. Additionally, the firm lacked specific written procedures for cleaning and sanitizing critical equipment components within the aseptic processing area.

Company: Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)
Inspection Date: August 8, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Amy Chua
Junho Pak (Investigator)

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ID · 33e97dae-850f-44fe-ae93-7066ca281f55