Taizhou Kangping Medical Science and Technology Co., Ltd.

Warning LetterOpen

Mr. Yuegen Wang General Manager Taizhou Kangping Medical Science and Technology Co., Ltd. Building 3, No 27 Tai’an Road Hailing Industrial Park Hailing Qu Taizhou Shi Jiangsu Sheng , 225300FEI 3013321339Issued Oct 9, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013321339.

Violations2

Issue DateOct 9, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Taizhou Kangping Medical Science and Technology Co., Ltd.
Location: Mr. Yuegen Wang General Manager Taizhou Kangping Medical Science and Technology Co., Ltd. Building 3, No 27 Tai’an Road Hailing Industrial Park Hailing Qu Taizhou Shi Jiangsu Sheng , 225300
FEI Number: 3013321339
Country: China
Issue Date: October 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Taizhou Kangping Medical Science and Technology Co., Ltd. was cited for Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter drugs, rendering their products adulterated. The FDA inspection (March 10-14, 2025) identified that the company failed to establish procedures to prevent microcontamination in products labeled as sterile, specifically finding that products purported to be sterile were actually non-sterile and lacked required sterility testing. The company's April 2025 response to the FDA 483 observations was deemed inadequate because it failed to implement corrective actions necessary to bring operations into compliance with CGMP requirements.

Taizhou Kangping Medical Science and Technology Co., Ltd. FDA Warning Letter, October 9, 2025