# FDA 483 - Hangzhou Linkeweier Daily Chemicals Co., Ltd. - September 17, 2019

Source: https://www.keypedia.com/records/483/hangzhou-linkeweier-daily-chemicals-co-ltd/37784b71-6ab7-4d73-bb3e-719804be4a0b

> FDA 483 for Hangzhou Linkeweier Daily Chemicals Co., Ltd. on September 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hangzhou Linkeweier Daily Chemicals Co., Ltd.
- Inspection Date: 2019-09-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hangzhou Linkeweier Daily Chemicals Co. Ltd. in Hangzhou, Zhejiang, revealed significant deficiencies across its quality, laboratory, material, production, and facilities systems. The firm, a finished drug product manufacturer, failed to establish and follow numerous written procedures, specifications, and testing programs essential for ensuring the identity, strength, quality, and purity of its OTC drug products. These widespread issues indicate a serious lack of control over critical manufacturing and quality processes.

## Related Officers

- [Laurimer Kuulan-Torres](https://www.keypedia.com/people/laurimer-kuulan-torres/c9c7d245-50a9-427b-962f-a50f00d7ada7)

Company: https://www.keypedia.com/companies/hangzhou-linkeweier-daily-chemicals-co-ltd/eb6be513-be1d-48f3-bc85-9392d066eebd

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