# FDA 483 - Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.) - March 27, 2026

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-frmly-twi-pharmaceuticals-inc/5f094a61-bb93-4e50-adb8-b4dd767fb759

> FDA 483 for Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.) on March 27, 2026. 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: 2026-03-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Bora Pharmaceutical Laboratories Inc. Zhongli Plant in Taoyuan City, Taiwan, was cited for significant deficiencies in its drug manufacturing operations. The inspection revealed critical issues including inadequate cleaning validation, repeated failures to investigate out-of-specification results and foreign matter, and insufficient controls over computerized systems. Additionally, the firm demonstrated poor management of manufacturing materials, indicating a systemic lack of quality control.

## Related Documents

- [483 - 2020-02-07](https://www.keypedia.com/records/483/bora-pharmaceuticals-frmly-twi-pharmaceuticals-inc/6af40762-6fc1-4b4c-b5ca-ba96c0a0ec31)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Statistical Science Director](https://www.keypedia.com/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8