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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.