# FDA 483 - Anqing Jiaxiin Medical Technology Co., Ltd. - October 23, 2019

Source: https://www.globalkeysolutions.net/records/483/anqing-jiaxiin-medical-technology-co-ltd/a1b8914c-9b23-42a7-88ea-d522b61b0948

> FDA 483 for Anqing Jiaxiin Medical Technology Co., Ltd. on October 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anqing Jiaxiin Medical Technology Co., Ltd.
- Inspection Date: 2019-10-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Anqing Jiaxin Medical Technology Co., Ltd. was cited for three observations during an FDA inspection. The firm failed to adequately establish process control procedures for heat sealers, did not properly control non-conforming products by misapplying its AQL sampling plan, and had inadequate procedures for controlling cleanroom environmental conditions. These issues indicate significant deficiencies in quality system controls for their Class I Cotton Tip Applicator products.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/anqing-jiaxiin-medical-technology-co-ltd/6ffc0fdf-1fc5-45b4-b2b6-0538805e9e1e

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