FDA Sends Warning Letters to 6 Foreign Device Firms for CGMP, Reporting Violations
The Food and Drug Administration sent out warning letters to six foreign device manufacturing facilities, according to recent postings on the FDA website. Xiantao Rayxin Medical Products Co. Ltd. of China (here), DMC Medical Technology & Manufacturing Co., Ltd. of…
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China (here), and EPS Biotechnology Corp. of Taiwan (here) were each sent warning letters for deviations from current good manufacturing practice (CGMP) requirements of FDA’s quality system regulations. Accordingly, FDA said the offending products were adulterated. Warning letters sent to Nissei Precision Instruments (Suzhou) Co., Ltd. of China (here), Copious International, Inc. of Taiwan (here), and SMT-Schilling Metalltechnik GmbH of Germany (here) not only detailed CGMP violations by each firm, but also said the firms failed to meet medical device reporting requirements because they failed or refused to provide required information to FDA. As a result, certain products manufactured by Nissei, Copious, and SMT-Schilling were found to be both adulterated and misbranded by FDA.