# FDA 483 - Sinopep-Allsino Biopharmaceutical Co., Ltd. - April 18, 2016

Source: https://www.globalkeysolutions.net/records/483/sinopep-allsino-biopharmaceutical-co-ltd/7f35b0e4-2222-4845-bf34-9a9033373806

> FDA 483 for Sinopep-Allsino Biopharmaceutical Co., Ltd. on April 18, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sinopep-Allsino Biopharmaceutical Co., Ltd.
- Inspection Date: 2016-04-18
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Sinopep Jiangsu Inc. in Lianyungang, China, identified one observation. The firm's Quality Department failed to calibrate a Long Term Stability Chamber after its temperature settings were changed to meet ICH Guidelines, and also lacked clear requirements for equipment requalification/recalibration following major changes.

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## Related Officers

- [Tracey L. Harris](https://www.globalkeysolutions.net/people/tracey-l-harris/08c88ca9-370f-4c6b-9e9d-04a5c24486ec)

Company: https://www.globalkeysolutions.net/companies/sinopep-allsino-biopharmaceutical-co-ltd/f45b83cf-0416-4308-92bf-f7f3212ca356

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321