# FDA 483 - Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/jiangsu-jiaerke-pharmaceuticals-group-corp-ltd/88731eb4-5ab6-4b2a-b83c-bc408946c100

> FDA 483 for Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. in Changzhou, China, an API manufacturer. The inspection revealed significant deficiencies in control record management, specifically regarding logbook reconciliation and the lack of hard-bounded, numbered pages. Additionally, the firm's quality assurance unit failed to conduct comprehensive reviews of electronic data and audit trails for analytical results.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/truong-xuan-nguyen/4ccdfd9f-f002-4498-829e-6e951e9d5e43)

Company: https://www.globalkeysolutions.net/companies/jiangsu-jiaerke-pharmaceuticals-group-corp-ltd/7ccd91ae-2b6a-43f7-acc5-6c182cec0d11

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1