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

Source: https://www.globalkeysolutions.net/records/483/puriblood-medical-co-ltd/0fb3b7b0-82ee-45e6-b5c0-3aaf1a599a31

> 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: Office of Inspections and Investigations
- Summary: An FDA inspection of PURIBLOOD MEDICAL CO., LTD, a medical device manufacturer in Baoshan Township, Taiwan, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including root cause analysis and verification of effectiveness. Additionally, complaint handling procedures were found to be inadequate, and controls over purchased products and services were not properly defined.

## Related Officers

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

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

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