Pharmaron (Ningbo) Technology Development Co., Ltd.November 1, 2024

FDA 483 - Pharmaron (Ningbo) Technology Development Co., Ltd. - November 01, 2024

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Record Details

An FDA inspection of Pharmeron (Ningbo) Technology Development Co. Ltd., an API manufacturer in Ningbo, China, revealed significant deficiencies in quality control. Observations included a lack of growth promotion testing for microbiological media, inadequate environmental monitoring in processing areas, and insufficient written procedures for raw material sampling. These issues indicate a failure to ensure drug product quality and compliance with manufacturing standards.

Company: Pharmaron (Ningbo) Technology Development Co., Ltd.
Inspection Date: November 1, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Marvin D. Jones (Investigator)

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ID · 92c2bad6-54a1-4f55-84db-c117e97228fa