Tianjin Bolang Science-Technology Development Co., Ltd.

Warning LetterOpen

Mr. Lin Qi General Manager Tianjin Bolang Science-Technology Development Co., Ltd. D-401, Hi-Tech Green Industrial Base Huayuan Industrial Area Tianjin Shi , 300384 ChinaIssued Jun 17, 2021Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations15

Issue DateJun 17, 2021

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Tianjin Bolang Science-Technology Development Co., Ltd.
Location: Mr. Lin Qi General Manager Tianjin Bolang Science-Technology Development Co., Ltd. D-401, Hi-Tech Green Industrial Base Huayuan Industrial Area Tianjin Shi , 300384 China
FEI Number: N/A
Country: China
Issue Date: June 17, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Tianjin Bolang Science-Technology Development Co., Ltd. manufactured otoscopes, rigid laryngoscopes, and rigid nasopharyngoscopes that were found to be adulterated due to failure to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The company had not established design control procedures for its private label endoscopic medical devices intended for the U.S. market, including Class II rigid nasopharyngoscopes, and failed to conduct required design and development activities for these devices. The inspection conducted March 22-30, 2021, identified these violations related to inadequate quality system controls and design control procedures.

Tianjin Bolang Science-Technology Development Co., Ltd. FDA Warning Letter, June 17, 2021