Navigation Links
Stryker's Biotech Division Receives FDA Warning Letter
Date:5/2/2008

KALAMAZOO, Mich., May 2 /PRNewswire-FirstCall/ -- Stryker Corporation (NYSE: SYK) announced today that its Biotech division has received a warning letter from the U. S. Food and Drug Administration (FDA) related to quality systems and compliance issues at its Hopkinton, Massachusetts location.

The warning letter concerns observations made during an inspection that was initiated in September 2007. The letter primarily cites issues relating to Stryker Biotech's handling of a past clinical study, its quality system including medical device reporting procedures, and the integrity of hospital Institutional Review Board (IRB) documentation used to approve implantation of Humanitarian Use Devices.

Several corrective actions and changes to processes put in place by Stryker Biotech were noted in the letter and future improvements are forthcoming as the division continues to work with FDA. No products have been recalled as a result of this warning letter. In addition, there were no observations related to any ongoing clinical trials or clinical trial IRBs.

"We take this matter very seriously, will continue to cooperate fully with FDA, and have initiated significant measures to address FDA's concerns," said Stephen P. MacMillan, President and Chief Executive Officer of Stryker Corporation.

In addition to specific corrective actions implemented at the Biotech division, Stryker recently launched a company-wide Quality Action Plan aimed at strengthening corporate-level oversight and at institutionalizing a more consistent implementation of best practices for meeting FDA requirements.

As part of its Quality Action Plan Stryker has:

-- Strengthened roles and responsibilities to increase accountability for'/>"/>

SOURCE Stryker Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. PulmoBioTech Announces Details of Its Regulatory Approval Experiments
2. Lixte Biotechnology Holdings Announces That Anti-Cancer Activity Against Glioblastoma in an Animal Model Was Reported at the Annual Meeting of the American Association of Cancer Research
3. Data From Ortho Biotech-Sponsored Studies to be Presented at National Kidney Foundation 2008 Spring Clinical Meetings
4. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
5. Kibow Biotech Obtains Australian, Chinese and Indian Patents Protecting the Composition and Basic Technology Behind Its Oral Probiotic Formulation for Chronic Kidney Failure
6. Hawaii Biotech Receives Allowance to Perform West Nile Vaccine Clinical Trials
7. Lixte Biotechnology Holdings, Inc. Announces Completion of Private Placement
8. Epeius Biotechnologies Applauds the Belated Scholarship of Their Academic Contemporaries in 2007, As Targeted Gene Therapy Comes of Age in Clinical Medicine
9. ASEAN News: Epeius Biotechnologies Gains Commercial Approval for Rexin-G(R), a Tumor-Targeted Gene-Based Medicine for Metastatic Cancer
10. Sangamo BioSciences and Sigma-Aldrich Announce Nature Biotechnology Study Demonstrating Zinc Finger Technology for Modification of Human Stem Cells
11. CEL-SCI CEO to Present Tomorrow at the Biotech / Pharma / Healthcare On-Line Forum
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... Oct. 22, 2014  Rescheduling of hydrocodone combination ... the pain market, according to a new primary ... firm providing market research and consultation exclusively in ... - http://photos.prnewswire.com/prnh/20141021/153440 In ... hydrocodone combination products from Schedule III to Schedule ...
(Date:10/22/2014)... 2014  Charlene Vernak, RPh, of Vernak Farms Pharmacy ... was awarded the George Roentsch Scholarship by the Professional ... in Houston during PCCA,s International ... annually to an independent pharmacist and PCCA member who ... Roentsch , a well-known pharmacist in the compounding community. ...
(Date:10/22/2014)... 22, 2014 AVACEN Medical announced today that ... (k) OTC clearance by the U.S. Food and Drug ... marketed over the Internet for: the temporary relief ... minor strains and sprains . Logo - ... (MSRP $2495) is a sophisticated medical device incorporating over ...
Breaking Medicine Technology:Hydrocodone: Rescheduled, Repositioned & Reinvented 2Hydrocodone: Rescheduled, Repositioned & Reinvented 3PCCA Awards Charlene Vernak, RPh, the George Roentsch Scholarship 2AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode 2
... , , ... it was awarded the 2009 Top Innovator Presentation Award,in ... on December 8th,at Dedham, MA. The award, which recognizes ... granted to Biovista who competed with,over 50 other privately ...
... , AMSTERDAM, December ... as Chief Executive Officer of its pharmaceutical,business. Gunnar Staaf ... Lilly & Company, in a range of commercial and ... plan to,spin-out its pharmaceutical business. The company intends to ...
Cached Medicine Technology:Biovista Inc. Named Top Innovator in Life Sciences 2Avantium Appoints Gunnar Staaf as CEO Pharma 2
(Date:10/22/2014)... Best Cheap Hosting USA is among ... site has recently announced that iPower ( http://www.best-cheap-hosting-usa.com/go/iPower/ ) ... from around the world. , “iPower is one of ... is providing various kinds of useful products for new ... offering excellent customer service and a number of features ...
(Date:10/22/2014)... October 22, 2014 Richard Carlson, Managing ... industry leader with over 25 years experience. Mr. ... in the areas related to EDI, B2B Commerce, RFID ... an Editorial Advisory Board member for Pharmaceutical Commerce Magazine ... Blue Fin Group is a management and technology consulting ...
(Date:10/22/2014)... Tara Haelle HealthDay Reporter , ... young adult men may lead to increased blood pressure, according ... a similar rise in blood pressure for young adult women ... young adult women drank lightly or moderately, their risk of ... "This finding parallels studies in older adult men and ...
(Date:10/20/2014)... The newly updated Worldwide Medical Market Forecasts ... facts, figures and forecasts on the global medical markets. ... categories the Worldwide Medical Market Forecasts to 2019 ... on the worldwide medical market to reveal key insights ... data for 2010-2019, covering each country market individually, allowing ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Women’s health ... in Obstetrics & Gynecology of Columbus, Inc., A Division ... healthcare services to more than 100,000 patients annually. Dr. ... all ages and stages of a women’s life. She ... locations in Westerville and Dublin. , Dr. Murphy ...
Breaking Medicine News(10 mins):Health News:Best Cheap Hosting USA Has Recently Announced The Best Cheap Web Hosting Companies In 2014 2Health News:Rich Carlson and Marc Duey to Hold Workshop at CBI’s Specialty Pharmacy and Distribution Networks Conference 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 3Health News:Binge Drinking May Boost Blood Pressure in Young Men 4Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 2Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 3Health News:Worldwide Medical Market Forecasts to 2019 a New Research Report Added to ReportsnReports.com 4Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 2Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 3
... linked to osteoporosis without the need for surgery. Researchers ... the effect of a new treatment for vertebral fractures ... acrylic cement into the affected area - a procedure ... reported substantial improvements - less pain, better sleep and ...
... American doctors, there is no upper age limit to the ... for detecting bowel cancer and polyps before any symptoms develop. ... a faecal occult blood test (FOBT), sigmoidoscopy or colonoscopy - ... a family history of colon cancer. // ,But it ...
... advertisements of prescription drugs, statements about drug benefits ... quantify the medications' expected benefit; instead, they make ... Medical School, Hanover, New Hampshire. // ... is that the medicine is going to prevent ...
... described as a process of bewitchment, but scientists have found ... the eye. They say female chemical messengers known as pheromones ... attractive and beautiful women are less attractive than they actually ... given off by the body - are thought to affect ...
... may be at risk of developing dangerously high blood pressure ... 10% of pregnant women suffer from pre-eclampsia, a condition in ... death in the mother and the foetus. ,Women can try ... But drugs may put the foetus at risk, and sometimes ...
... will provide the most effective defence against bioterrorism. ... in understanding of diseases like anthrax and botulism, ... protect society against bioterrorist attacks - as well as ... for the Advancement of Science (AAAS) heard from Colonel ...
Cached Medicine News:Health News:The phenomenon of sexual attraction, 2Health News:Snoring could be a warning 2Health News:Biotechnology on the lead 2
Carl Zeiss immersion oils are PCF free. They are quality controlled for two wavelengths of light, Ne=1.518 and Nd=1.515 at 23ºC....
Immersion oils may crystallize on storage. Can be redissolved on heating to 50ºC (1-2 hours)...
... Oils are the standard - the ones to ... Laboratories has consistently led in the development and ... Here is the record: , When the FDA ... of In Vitro Diagnostics in the 1970's, Cargille ...
... an Informatics software product enabling quick and ... the laboratory. With SpecTRACK Software, users can ... specimen from all laboratories in their LAN ... or cold room. Automate your existing manual ...
Medicine Products: