# FDA 483 - NIPRO CANADA CORPORATION - May 31, 2018

Source: https://www.globalkeysolutions.net/records/483/nipro-canada-corporation/81f11a24-13b2-4600-9ff8-be158473dc82

> FDA 483 for NIPRO CANADA CORPORATION on May 31, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NIPRO CANADA CORPORATION
- Inspection Date: 2018-05-31
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Cardiomed Supplies, Inc., a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately validate critical processes like pouch sealing and Ethylene Oxide sterilization, and lacked proper procedures for corrective and preventive actions and design validation. Additionally, their risk analysis was incomplete, failing to address known hazards with kit components.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/lisa-a-warner/3c039e9f-4349-4f3c-bac0-4d12c2cc0660)

Company: https://www.globalkeysolutions.net/companies/nipro-canada-corporation/f2428836-135f-4fba-a1a0-59f37895f6f8

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd