# FDA 483 - Conod Medical Co., Limited - July 30, 2015

Source: https://www.globalkeysolutions.net/records/483/conod-medical-co-limited/94d3908b-c1a2-4b13-b056-1c5ccd656c22

> FDA 483 for Conod Medical Co., Limited on July 30, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Conod Medical Co., Limited
- Inspection Date: 2015-07-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Conod Medical Co., Limited, a medical device manufacturer in Changshu City, China, was cited with two observations during an FDA inspection. The observations concern inadequate process validation for sterile packaging and insufficient procedures for acceptance activities related to bubble leak testing for urine bag devices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/leighton-k-ngai/39fc01c8-e40a-45d4-910a-068955d16a06)

Company: https://www.globalkeysolutions.net/companies/conod-medical-co-limited/ae06eede-c297-47d1-8bd7-587e8ef32c67

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