Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.)February 7, 2020

FDA 483 - Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.) - February 07, 2020

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Record Details

TWi Pharmaceuticals, Inc. in Taoyuan, Taiwan, received a Form 483 for deficiencies related to equipment cleaning and maintenance. Inspectors observed residues on air supply diffusers in a production room and found that cleaning procedures lacked sufficient detail and validation data. These issues indicate a failure to prevent contamination and ensure the quality of drug products.

Company: Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.)
Inspection Date: February 7, 2020
Product Type: Drugs
Office: Division of Human and Animal Food East V Compliance Branch
Person: Zhongren Wu (Principal Consultant)

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ID · 6af40762-6fc1-4b4c-b5ca-ba96c0a0ec31