# FDA 483 - Taizhou Kangping Medical Science And Technology Co., Ltd. - March 07, 2019

Source: https://www.keypedia.com/records/483/taizhou-kangping-medical-science-and-technology-co-ltd/4e64c730-ae3d-4da7-be44-aa5a163867a9

> FDA 483 for Taizhou Kangping Medical Science And Technology Co., Ltd. on March 07, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Taizhou Kangping Medical Science And Technology Co., Ltd.
- Inspection Date: 2019-03-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Taizhou Kangping Medical Science and Technology Co., Ltd., an OTC drug manufacturer in Taizhou City, Jiangsu, China, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate out-of-specification results, did not use unique lot numbers for drug products, and maintained deficient master production and control records. These issues indicate a lack of adequate controls to ensure product quality and traceability.

## Related Documents

- [483 - 2025-03-14](https://www.keypedia.com/records/483/taizhou-kangping-medical-science-and-technology-co-ltd/7436045d-3bef-4177-90bf-6c39e037c22f)
- [WARNING_LETTER - 2025-03-14](https://www.keypedia.com/records/warning_letter/taizhou-kangping-medical-science-and-technology-co-ltd/dd28d7d2-7999-44fa-b259-5a9bd11e7240)

## Related Officers

- [investigator](https://www.keypedia.com/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)

Company: https://www.keypedia.com/companies/taizhou-kangping-medical-science-and-technology-co-ltd/0d82e4b0-a4d9-4b6f-b188-651173269c70

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