Navigation Links
Many Non-U.S. Firms Affected by U.S. FDA Import Alert 80-04 for Medical Glove Manufacturing Defects, According to, LLC

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, 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,, 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, LLC show you ‘the way through.”, 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, LLC. Foreign and domestic manufacturers who are in one of the above mentioned situations, or who desire to avoid such expensive problems, should contact, LLC for expert advice and support.


Read the full story at

Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related medicine news :

1. Administrations Budget Affirms Commitment to Veterans, say Coauthors of The Independent Budget
2. Jackson & Coker Ranks #3 among “Ten Best Staffing Firms to Work For”
3. Luckey & Mullins Joins with Other National Construction Defect Law Firms to Form Chinese Drywall Legal Network
4. Definitive study confirms chemo benefit in postmenopausal breast cancer
5. Study confirms accuracy of transient elastography in NAFLD
6. Study confirms prostate cancer is treated differently at county vs. private hospitals
7. Watson Confirms Filing of FDA Application for Generic Lidoderm(R)
8. Medicare Report Confirms Health Care Takeover Plan is a Fiscal Disaster
9. New Study Confirms Health Benefits of Pecorino Romano Cheese
10. CBO Confirms That Premiums Will Increase Under the Senate Healthcare Reform Bill
11. TYLENOL Recall Confirms Congress, FDA Must Regulate Wood Pallets to Prevent Threats to U.S. Food, Drug Supply
Post Your Comments:
Related Image:
Many Non-U.S. Firms Affected by U.S. FDA Import Alert 80-04 for Medical Glove Manufacturing Defects, According to, LLC
(Date:11/25/2015)... ... November 25, 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical ... its 65th Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this ... Brillianteen has been a treasured tradition for numerous families in the Evanston community. ...
(Date:11/25/2015)... ... 25, 2015 , ... Castlewood Treatment Center for Eating Disorders, ... as a result of the $20,000 raised at the center’s recent golf ... Club in Eureka, will help individuals who otherwise might not seek treatment for ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely ... resulting in a way for homeless people to have a more dignified and ... new initiative whereby they are repurposing plastic bags into sleeping mats for the ...
(Date:11/25/2015)... CA (PRWEB) , ... November 25, 2015 , ... Students ... prizes were awarded to winners of the Create Real Impact awards. California Casualty ... expression to help stem the tide of distracted and reckless driving, the number one ...
(Date:11/24/2015)... ... November 24, 2015 , ... Dr. Todd S. Afferica, a noted general ... of his patients. Dr. Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many ... the doctor uses other traditional cutting tools, such as the scalpel and high-speed drill, ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)...  Thanks to a donor with a personal connection ... Sister Diane Grassilli Center for Women,s Health now offers ... San Francisco . Fred Ruhland ... a gift of $617,320 that allowed the Center to ... and Whole Breast Ultrasound. Tomosynthesis, three-dimensional (3-D) mammography for ...
(Date:11/24/2015)... Nov. 24, 2015  In the pharmaceutical industry, companies ... effort to quickly uncover new insights, tactics and strategies ... --> --> However, organizations often find ... project and ensure that all rules and regulations are ... Another major barrier to efficiently launching market research projects ...
(Date:11/24/2015)... New York , 24. November 2015 ... des Avery Breathing Pacemaker Systems, ist erfreut, ... als Clinical Consultant bekannt geben zu können. ...   --> Foto ... Stockholm (Schweden). Von 1984-1986 war ...
Breaking Medicine Technology: