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* You are viewing Posts Tagged ‘mold’

FDAImports.com Overcomes Import Alerts and Other Obstacles: 2 Success Stories

admin July 20, 2011 Company News, Imports, Law & Regulatory No Comments

Tags: 23-14, 86-07, aflatoxin, alert, case studies, contamination, delays, FDA, food, import, import alert, mold, releases, shipments, snacks, sunglasses, testing

FDA Import Alerts

FDAImports.com recently declared victory for two clients with many shipments of products under FDA automatic detention due to FDA Import Alerts.  An Import Alert will always cause shipment delays, supply-chain risks, increased costs and budget overages, not to mention the additional burden it places on a supplier to prove to FDA why they should not be on Import Alert.  FDAImports.com is pleased to report on two recent success stories of obtaining removal from FDA Import Alert on relatively short time frames.
Case #1: Sunglasses (Import Alert #86-07)
FDA began automatically … READ MORE

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FDA Clarifies its Concerns about Medical Devices from Japan

admin June 03, 2011 Law & Regulatory, Medical Devices No Comments

Tags: animal electrical, CBER, CDRH, Center for Biologic Evaluation and Research, Center for Device and Radiological Health, compliance, detention, documentation, drug, earthquake, exporters, FDA, food, import, inspection, inspections, japan, laboratory, medical devices, mold, regulation, regulatory, safety, sterile, sterilization, temperature control, testing, united states, violations, water

FDA Medical Device RegulationIn a previous FDAImports.com article on the Japan Earthquake it was stated that FDA-regulated products from Japan will likely face many new hurdles in order to enter the United States. FDA will likely subject them to greater regulatory review by inspecting incoming food, drugs and medical devices and possibly subjecting them to laboratory testing.

On June 1, 2011, the Center for Device and Radiological Health (“CDRH”) and the Center for Biologic Evaluation and Research (“CBER”) issued a … READ MORE

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