FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Chinese Manufacturer Cited for Sanitation, Sterility Issues

Jan. 12, 2018

The FDA hit Chinese API manufacturer Jiangsu Yongan Pharmaceuticals with a Form 483 over serious deficiencies relating to poor sanitation, record keeping and training.

During a July inspection at the firm’s Huaian, Jiangsu facility, FDA investigators observed significant sanitation violations that could cause product contamination. Cobwebs, rust, flaking paint and peeling tape were observed on overhead pipes and structures in the facility above an area frequently open to ingredients.

The agency found tape was used extensively on piping and was coming off in multiple areas, while cleaned equipment was placed on racks, uncovered, near open windows with no controls to prevent the entry of outside contaminants.

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