On Oct. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Oct. 17 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
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 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.
On Oct. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 12-14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Oct. 10 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration updated its Progress Report on Implementing the Food Safety Modernization Act (FSMA) for July through September 2012. According to the report, progress was made in the following areas:
On Oct. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: