# FDA 483 - PURIBLOOD MEDICAL CO., LTD - March 14, 2025

Source: https://www.keypedia.com/records/483/puriblood-medical-co-ltd/e6923826-20b0-44d0-81f8-c9aa309dd263

> FDA 483 for PURIBLOOD MEDICAL CO., LTD on March 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PURIBLOOD MEDICAL CO., LTD
- Inspection Date: 2025-03-14
- Product Type: device
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of PURIBLOOD MEDICAL CO., LTD in Baoshan Township, Taiwan, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for corrective and preventive actions, particularly regarding root cause analysis and effectiveness verification. Additionally, the firm failed to adequately establish procedures for complaint handling and ensuring purchased products and services conform to specified requirements.

## Related Documents

- [483 - 2025-03-14](https://www.keypedia.com/records/483/puriblood-medical-co-ltd/0fb3b7b0-82ee-45e6-b5c0-3aaf1a599a31)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [Nisha C. Patel](https://www.keypedia.com/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)

Company: https://www.keypedia.com/companies/puriblood-medical-co-ltd/3bd872cd-15b6-4f8b-a254-bd066400fb8e

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917