N.J. company's IMDs seized due to manufacturing deficiencies

April 2007
Medical Device Daily;4/19/2007, Vol. 11 Issue 75, p3
The article reports on the seizure of all implantable medical devices from Shelhigh by U.S. marshals and the investigators of the U.S. Food and Drug Administration (FDA). According to the FDA, there were significant deficiencies in the company's manufacturing processes. The agency needs all medical device companies to follow current good manufacturing practice.


Related Articles

  • Shelhigh 'disappointed' by FDA seizure, says issues addressed.  // Medical Device Daily;4/24/2007, Vol. 11 Issue 78, p3 

    The article reports on the reaction of medical device firm Shelhigh to the claims by the U.S. Food and Drug Administration (FDA) regarding its seizure of implantable medical devices. Shlomo Gabbay, founder and chief scientific officer of Shelhigh, expressed his disappointment to the agency's...

  • Shelhigh to cease distribution, agrees to FDA standards. Pedersen, Amanda // Biomedical Business & Technology;Aug2007, Vol. 30 Issue 8, p23 

    The article reports that Shelhigh has agreed in July 2007 to cease the distribution of its implantable medical devices used in heart surgery and other procedures until it has complied with the U.S. Food and Drug Administration (FDA) standards in its production processes. Citing concerns for...

  • FDA panel recommends approval of ceramic-on-metal hip implant. Press, Robert // Orthopedics Today;Sep2009, Vol. 29 Issue 9, p46 

    The article reports on the approval given by the Orthopaedic and Rehabilitation Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) to the recommendation of the Pinnacle CoMplete Acetabular Hip System (DePuy), the first ceramic-on-metal hip implant.

  • FDA reports problems with a recent 510(k) clearance process. Rapp, Susan M. // Orthopedics Today;Nov2009, Vol. 29 Issue 11, p62 

    This article reports on the key findings of a review by the U.S. Food and Drug Administration (FDA) of internal processes surrounding the December 2008 510(k) clearance of a collagen meniscus implant.

  • Tami-Fakes. Herper, Matthew // Forbes Asia;2/13/2006, Vol. 2 Issue 2, p18 

    The article presents information on the seizure of shipments of pills ordered online in San Francisco, California in December 2005. The confiscated pills were labeled as generic Tamiflu and has been high in demand because it could help contain a bird flu pandemic. The U.S. Food & Drug...

  • FDA getting tougher. Colford, Steven W. // Advertising Age;4/29/1991, Vol. 62 Issue 18, p1 

    Reports on the seizure of a number of Citrus Hill Fresh Choice orange juice of Procter & Gamble Co. by the U.S. Food & Drug Administration (FDA). Significance of the seizure; Statement from FDA Commissioner David Kessler; Reaction from several food companies.

  • FDA Gives GSK Angst on Paxil. Edwards, Jim // Brandweek;3/7/2005, Vol. 46 Issue 10, p7 

    Reports on the action taken by the U.S. Food and Drug Administration (FDA) to seize supplies of GlaxoSmithKline (GSK) drugs, anxiety/depression treatment Paxil CR and diabetes treatment Avandamet as of March 7, 2005. Locations of the raids; Failure of the pills to meet the FDA standards;...

  • Dental devices seized.  // Medical Device Daily;1/14/2011, Vol. 15 Issue 10, p8 

    The article reports on the seizure by U.S. marshals of dental devices from Rite-Dent Manufacturing. According to the Food and Drug Administration (FDA), the seizure involved the confiscation of products valued at around 209,000 U.S. dollars. It notes that the action came after an inspection...

  • Contaminated Honey Seized.  // FDA Consumer;May/Jun2003, Vol. 37 Issue 3, p6 

    Reports the seizure of contaminated imported honey by U.S. Marshals at the request of the Food and Drug Administration. Background on the contaminant chloramphenicol.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics