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

Source: https://www.globalkeysolutions.net/records/483/bora-pharmaceuticals-frmly-twi-pharmaceuticals-inc/6af40762-6fc1-4b4c-b5ca-ba96c0a0ec31

> FDA 483 for Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.) on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.)
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food East V Compliance Branch
- Summary: 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.

## Related Officers

- [Principal Consultant](https://www.globalkeysolutions.net/people/zhongren-wu/416f09a6-f225-4d23-a305-34f96a5c78f0)

Company: https://www.globalkeysolutions.net/companies/bora-pharmaceuticals-frmly-twi-pharmaceuticals-inc/103fb1af-ac77-4f76-9476-8430e4586638

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-east-v-compliance-branch/00f6013b-7c92-4daf-ae51-d47ab44bf1cb