# FDA 483 - Co-Innovation Biotech Co., Ltd. - January 09, 2020

Source: https://www.keypedia.com/records/483/co-innovation-biotech-co-ltd/b7db6e67-d21a-48dc-9d03-8e180412adf3

> FDA 483 for Co-Innovation Biotech Co., Ltd. on January 09, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Co-Innovation Biotech Co., Ltd.
- Inspection Date: 2020-01-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Co-Innovation Biotech Co. Ltd., a medical device manufacturer in Guangzhou, China, was cited for multiple quality system deficiencies during an FDA inspection. Observations included a lack of validation for a seal tester used for HCG test kits, undocumented equipment calibrations, and inadequate documentation of corrective and preventive actions. The firm also failed to record environmental conditions as required and used unapproved forms, indicating significant issues with their quality management system.

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/co-innovation-biotech-co-ltd/8511a9fd-0b42-4fd0-8484-33cd1bc77fb0

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