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:1/15/2014)... BreedIT Corp (OTC: BRDT), through its ... highly sophisticated agro-breeding solutions for plant breeders and researchers, ... board of directors appointed chemistry and pharmaceutical industry expert ... of the board. From 1975 to 2012, ...
(Date:1/15/2014)... 15, 2014 MultiCell Technologies, Inc. (OTC Bulletin Board: ... patent application concerning composition of matter, biological targets, mechanism ... cell death.  This patent application describes ... RNA molecules (VSRNAs) which interfere with the basic homeostatic ...
(Date:1/15/2014)... 2014 Reportlinker.com announces that a new ... catalogue: Insulin Pump ... http://www.reportlinker.com/p01957812/Insulin-Pump-Market--Forecast-–-Worldwide-Analysis.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Equipment_and_Supply ... Insulin Pumps are gaining strong acceptance ...
Breaking Medicine Technology:BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 2BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 3MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3Insulin Pump Market & Forecast - Worldwide Analysis 2Insulin Pump Market & Forecast - Worldwide Analysis 3Insulin Pump Market & Forecast - Worldwide Analysis 4Insulin Pump Market & Forecast - Worldwide Analysis 5Insulin Pump Market & Forecast - Worldwide Analysis 6Insulin Pump Market & Forecast - Worldwide Analysis 7Insulin Pump Market & Forecast - Worldwide Analysis 8Insulin Pump Market & Forecast - Worldwide Analysis 9Insulin Pump Market & Forecast - Worldwide Analysis 10Insulin Pump Market & Forecast - Worldwide Analysis 11Insulin Pump Market & Forecast - Worldwide Analysis 12Insulin Pump Market & Forecast - Worldwide Analysis 13Insulin Pump Market & Forecast - Worldwide Analysis 14Insulin Pump Market & Forecast - Worldwide Analysis 15Insulin Pump Market & Forecast - Worldwide Analysis 16Insulin Pump Market & Forecast - Worldwide Analysis 17
... 11 Chimerix, Inc., a,biotechnology company developing orally ... initiated a multi-dose trial with its,lead drug candidate, ... will study the pharmacokinetics and safety of three ... "The high oral availability demonstrated by CMX001 in ...
... works with hospitals to help reduce spread of ... national forum on quality in,health care, Highmark officials ... designed to deal with Methicillin,Resistant Staphylococcus Aureus (MRSA). ... hospitals in western,Pennsylvania in identifying patients that have ...
Cached Medicine Technology:Chimerix Initiates a Multi-dose Clinical Trial of the Company's Lead Compound, CMX001, for the Treatment for Smallpox Infection 2Highmark Presents Work on MRSA Prevention at National Health Care Quality Conference 2
(Date:4/17/2014)... 2014 By discovering a new mechanism that allows ... researchers at UC Irvine and the Salk Institute have ... or prevent stroke-induced brain damage. , A complex and ... death and primary reason for disability in the U.S. ... and lets blood-borne material into the brain, causing the ...
(Date:4/17/2014)... April 17, 2014 EcoHealth Alliance, a nonprofit ... issues, published a comprehensive review today examining the current ... virus. The review calls for improved global surveillance strategies ... the recent outbreak of Ebola in West Africa that ... countries of Guinea and Liberia. According to the ...
(Date:4/17/2014)... Spending time online has the potential to ward off ... according to research published online in The ... Sciences . In the article " Internet Use ... States: A Longitudinal Analysis ," the authors report that ... by 33 percent among their study sample. , ...
(Date:4/17/2014)... Council scientists and their partners have found that their ... the transmission of multiple sexually transmitted infections (STIs) in ... simplex virus 2 (HSV-2), and human papillomavirus (HPV). The ... gel is effective against multiple strains of HIV, and ... all three viruses of at least eight hours prior ...
(Date:4/17/2014)... April 17, 2014 Meaningful long-term survival is ... of the abdomen when treated with cytoreductive surgery ... a first-of-its-size analysis by physicians at Wake Forest ... the largest reported, single-center experience with cytoreductive surgery ... M.D., and analysis of 20 years, worth of ...
Breaking Medicine News(10 mins):Health News:Study IDs new cause of brain bleeding immediately after stroke 2Health News:Re-emergence of Ebola focuses need for global surveillance strategies 2Health News:Re-emergence of Ebola focuses need for global surveillance strategies 3Health News:Internet use may cut retirees' depression 2Health News:Animal study provides first evidence that gel can prevent multiple virus transmission in vagina/rectum 2Health News:20 years of data shows treatment technique improvement for advanced abdominal cancer 2
... RI A new study by Rhode Island Hospital ... eating disorders have limited clinical utility. Researchers recommend a ... eating disorder. , In the DSM-IV manual, bulimia and ... defined eating disorders. A third, binge eating disorder, is ...
... LOUIS, Feb. 5 Young Innovations, Inc.,(Nasdaq: YDNT ) ... 2007., Sales for the fourth quarter of 2007 were ... $24.8 million reported in the fourth,quarter of 2006. Income from ... 2006 to $5.1 million in the fourth quarter of,2007. Net ...
... A Road Taken Together, NORTH ADAMS, Mass., ... across the globe will join the National,Patient Safety ... 2-8. The theme of the week, Patient Safety: ... safer health care through partnership,among providers, patients, families ...
... retrieve long-lost details , , TUESDAY, Feb. 5 (HealthDay News) ... details hidden in the long-term memories of people with ... about whether long-term memory is always dependent on a ... the memory-processing center called the hippocampus. , This study, ...
... Percent Growth ... - Special ... Edwards Lifesciences,Corporation (NYSE: EW ), a world leader in products ... ended December 31, 2007 of $15.8 million, or $0.27 per diluted,share, compared ...
... AtriCure, Inc.,(Nasdaq: ATRC ), a medical device company ... its financial results for the fourth,quarter and full year ... AtriCure will host a conference call at 10:00 a.m. ... and full year 2007 results. A,live web cast of ...
Cached Medicine News:Health News:New Rhode Island Hospital study shows inadequate diagnostic criteria for eating disorders 2Health News:Young Innovations, Inc. Announces Results for 4th Quarter and the Year and Declares Dividend 2Health News:Young Innovations, Inc. Announces Results for 4th Quarter and the Year and Declares Dividend 3Health News:Young Innovations, Inc. Announces Results for 4th Quarter and the Year and Declares Dividend 4Health News:Young Innovations, Inc. Announces Results for 4th Quarter and the Year and Declares Dividend 5Health News:Young Innovations, Inc. Announces Results for 4th Quarter and the Year and Declares Dividend 6Health News:Young Innovations, Inc. Announces Results for 4th Quarter and the Year and Declares Dividend 7Health News:Patient Safety Awareness Week March 2 to March 8, 2008 2Health News:Brain Injury May Not Erase Long-Term Memory 2Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 2Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 3Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 4Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 5Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 6Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 7Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 8Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 9Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 10Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 11Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 12Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 13Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 14Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 15Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 16Health News:Edwards Lifesciences Reports Strong Fourth Quarter Sales 17Health News:AtriCure Announces Web Cast and Conference Call of Fourth Quarter and Full Year 2007 Financial Results 2
An enzyme-linked immuno-sorbent assay for the detection and quantitation of anti-tissue Transglutaminase in serum of patients with Celiac Disease and Dermatitis Herpetiformis....
Enzyme immunoassay for the quantitative determination of Gliadin-IgG antibodies in serum and plasma. This kit provides specific determination of gliadin antibodies by using highly purified gliadin....
... can operate with batches of 60 ... addition of optional Load/Unload Trays, and ... AX-4280 is a benchtop urine chemistry ... reliability providing the laboratory with a ...
... This Free Estriol ELISA kit is ... Estriol in human serum or plasma. This ... competitive ELISA. The samples, standards, and controls ... wells coated with anti-Estriol antibody. Free ...
Medicine Products: