483
Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.)Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.) – FDA 483, Feb 7, 2020
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.
- Inspection date
- February 7, 2020
- Product type
- drugs
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ID · 6af40762-6fc1-4b4c-b5ca-ba96c0a0ec31
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