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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

On March 24, 2010, FDA reissued Import Alert #80-04, “Surveillance and Detention Without Physical Examination of Surgeon’s and Patient Examination Gloves” (IA 80-04). Since the first of the year, FDA has placed fifteen (15) manufacturers and/or shippers on Import Alert #80-04; two of which were listed multiple times and one which has been relisted as a Level 2 violation.

Washington, DC (Vocus) May 3, 2010 -- In a time when American consumers are increasingly concerned with good health and virus or bacteria protection, most are not aware just how many companies the U.S. Food and Drug Administration (“FDA”) has targeted for having sold into the US market medical gloves with holes, or other dangerous defects. FDA regulates all domestic and imported medical devices such as medical gloves. On March 24, 2010, FDA reissued Import Alert #80-04, “Surveillance and Detention Without Physical Examination of Surgeon’s and Patient Examination Gloves” (IA 80-04). Since the first of the year, FDA has placed fifteen (15) manufacturers and/or shippers on Import Alert #80-04; two of which were listed multiple times and one which has been relisted as a Level 2 violation.

According to Benjamin L. England, of FDAImports.com, LLC, “… if you get caught shipping subpar medical gloves once, FDA requires you to make 5 consecutive clean shipments to get off the alert. That means 5 separate occasions of having your shipment stuck in port and five separate expensive lab tests you have to
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Source: PRWeb
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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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