# FDA 483 - Conod Medical Co., Limited - May 30, 2013

Source: https://www.keypedia.com/records/483/conod-medical-co-limited/d528aa97-24b8-4453-b0dc-25f1c1e45d68

> FDA 483 for Conod Medical Co., Limited on May 30, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Conod Medical Co., Limited
- Inspection Date: 2013-05-30
- Product Type: device
- Office Name: Division of International Drug Quality
- Summary: Conod Medical Co., Limited, a medical device manufacturer in Changshu, China, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate process validation for catheter tubing, a lack of established corrective and preventive action procedures, and sampling plans not based on valid statistical rationale. These issues indicate a failure to ensure product quality and address nonconformities effectively.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-w-plucinski/052e3737-6393-4c31-b11f-e382a46dea53)

Company: https://www.keypedia.com/companies/conod-medical-co-limited/fc7770b7-0ab4-4d2e-87c5-17069e35ca0f

Office: https://www.keypedia.com/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591