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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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.

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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.

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 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 even petition FDA to obtain removal from the alerts.” The Alert states that after a third violation, the FDA’s Center for Device and Radiological Health (CDRH) will likely require the firm to undergo an FDA inspection or audit, and will require extensive proof to be removed from the Import Alert.

Whether your firm is in violation of Level 1, 2 or 3, FDAImports.com, LLC can help you get off IA 80-04. If you have entries subject to detention for apparent violations, or are simply concerned about your firm’s regulatory compliance, let FDAImports.com, LLC show you ‘the way through.” FDAImports.com, LLC is a consulting firm that can help your company get off of an Import Alert, as well as provide guidance to avoid future violations. Save your firm from expensive and time consuming delays, like that which IA 80-04 can cause, by contacting FDAImports.com, LLC. Foreign and domestic manufacturers who are in one of the above mentioned situations, or who desire to avoid such expensive problems, should contact FDAImports.com, LLC for expert advice and support.

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Rick Quinn
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