Navigation Links
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 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.

###

Read the full story at http://www.prweb.com/releases/FDA_Import_Alert/Medical_Glove_Defects/prweb3957724.htm.


'/>"/>
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:
*Name:
*Comment:
*Email:
Related Image:
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:10/13/2017)... ... October 13, 2017 , ... While it’s often important ... problem. Fortunately, an inventor from Austin, Texas, has identified a solution. , She developed ... darkness or restricted lighting. As such, it eliminates the need to turn on a ...
(Date:10/13/2017)... ... October 13, 2017 , ... Southern ... and Jennifer Huggins, PharmD ’17, along with clinical associate professor Janice Frueh, ... cardiovascular diseases during the 15th Annual Women’s Health Conference. The SIU School ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills ... specialty vendors and unique items from across the nation, this holiday-themed event will raise ... offered by the VNA. The boutique will be open Saturday, November 4 (10:00 ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob Lowe, ... in a new episode of "Success Files," which is an award-winning educational program ... investigates each subject in-depth with passion and integrity. , Sciatica occurs when the ...
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... R.I. , Sept. 25, 2017  EpiVax, ... assessment, vaccine design, and immune-engineering today announced the ... on the development of personalized therapeutic cancer vaccines. ... has provided exclusive access to enabling technologies to ... Eng., MBA will lead EpiVax Oncology as Chief ...
(Date:9/19/2017)... ZirMed Inc ., a recognized leader in cloud-based revenue cycle ... ranked #1 by its users for the seventh consecutive year ... ZirMed was recognized as the top-ranked end-to-end revenue cycle management ... 200 beds and holds one of the longest #1 ranking ... ...
(Date:9/12/2017)... -- Consumer reviews on the independent review site Consumer Affairs ... for hearing aids, ranking it higher than Miracle Ear ™, ... ... Hearing Aids ... store that provides high performance, state-of-the-art, German-engineered hearing aids directly to ...
Breaking Medicine Technology: