# FDA 483 - Huaian Zongheng Bio-Tech Co., Ltd - July 05, 2019

Source: https://www.keypedia.com/records/483/huaian-zongheng-bio-tech-co-ltd/2e4f9b3c-53af-4fdb-8a36-93731df32458

> FDA 483 for Huaian Zongheng Bio-Tech Co., Ltd on July 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huaian Zongheng Bio-Tech Co., Ltd
- Inspection Date: 2019-07-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Huaian Zongheng Bio-Tech Co., Ltd, a drug manufacturer in Huaian, China, from July 1-5, 2019, revealed significant deficiencies across multiple quality systems. The firm failed to ensure proper laboratory controls, stability testing, process validation, and equipment calibration. These issues indicate a lack of adequate controls to assure the identity, strength, quality, and purity of drug products.

## Related Documents

- [WARNING_LETTER - 2019-07-05](https://www.keypedia.com/records/warning_letter/huaian-zongheng-bio-tech-co-ltd/e4a2ce4e-df72-45fd-b748-6d30c66264ab)

## Related Officers

- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

Company: https://www.keypedia.com/companies/huaian-zongheng-bio-tech-co-ltd/ef52dc53-00d7-40bb-8f38-afc441141f77

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