# FDA 483 - NingBo Huize Commodity Co.,Ltd. - March 22, 2019

Source: https://www.keypedia.com/records/483/ningbo-huize-commodity-coltd/71edf08d-f94f-4ab5-a5a4-21f3a3cf5eb6

> FDA 483 for NingBo Huize Commodity Co.,Ltd. on March 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NingBo Huize Commodity Co.,Ltd.
- Inspection Date: 2019-03-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of NingBo Huize Commodity Co.,Ltd. in Yuyao, China, a drug manufacturer, revealed significant deficiencies in its quality control unit and manufacturing processes. The firm was cited for providing false documentation and data, lacking essential validation programs, and failing to establish adequate laboratory and production controls. These observations indicate a severe lack of adherence to good manufacturing practices, impacting the identity, strength, quality, and purity of drug products.

## Related Officers

- [investigator](https://www.keypedia.com/people/jose-o-hernandez/960bffbe-1b8e-41bc-b203-aee88d7d8dac)

Company: https://www.keypedia.com/companies/ningbo-huize-commodity-coltd/5a71129a-73e8-4d6a-bbe2-907070ef3186

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