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Many Non-U.S. Firms Affected by U.S. FDA Import Alert 80-04 for Medical Glove Manufacturing Defects, According to FDAImports.com, LLC
Date:5/3/2010

pay for. If you get caught twice within 24 months [Level 2 violation, you’ll need to have 10 consecutive clean shipments to get off the alert. If you get caught a third time…your firm is facing serious charges, fines, and probably a foreign visit from FDA.”    

Fifteen medical glove manufacturers have been added to Import Alert #80-04 in the first four months of 2010. Since 1992, well over a hundred (100) other firms have been put on the automatic detention or “Red List” for shipping substandard medical gloves. If FDA finds an importer or manufacturer who shipped even one shipment of defective gloves, FDA places that firm on IA 80-04—which entails automatic detention of that firm’s products at the Customs Port of Entry.

England described this alert as different from others FDA has issued. “This alert has three levels of violation, each of which progressively worsens the consequences for the foreign manufacturer.” Firms that ship a single defective set of gloves will be placed on Level 1. Firms on Level 1 are subject to having their shipments Detained Without Physical Examination (DWPE), but can get their future shipments released after providing evidence that the gloves in that shipment are not defective (adulterated). After a series of consecutive non-defective shipments, they can petition FDA seeking removal from the alert. However, even if they are taken off the alert, a subsequent violation will lead to inclusion on the Level 2 list. Once on Level 2, firms will need to produce substantially more consecutive clean shipments to be removed from the Import Alert. “Most companies do not realize that even after shipping the clean shipments, the petition process takes time: meaning that still more shipments will have to be tested before FDA will stop automatically detaining their products. A surprising number of firms are not aware of the fact that they can
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Many Non-U.S. Firms Affected by U.S. FDA Import Alert 80-04 for Medical Glove Manufacturing Defects, According to FDAImports.com, LLC
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