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

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.