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

quality

-- Established new company-wide standard operating procedures for quality

processes that will be implemented consistently at each division

-- Reorganized quality functions at the plant, division and corporate

levels and increased third-party monitoring at all levels

-- Tied a significant portion of senior management's compensation to

meeting quality improvement measures

"We are committed to strengthening our quality systems to fully meet all FDA requirements. While we have made progress in fulfilling this commitment, we still have more work to do" MacMillan added.

Forward-Looking Statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause the Company's actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for the Company's products; regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; changes in economic conditions that adversely affect the level of demand for the Company's products; changes in foreign exchange markets; changes in financial markets; and changes in the competitive environment. Additional information concerning these and other factors is contained in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; and endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at http://www.stryker.com .


'/>"/>
SOURCE Stryker Corporation
Copyright©2008 PR Newswire.
All rights reserved

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:3/30/2017)... , March 30, 2017  Akcea Therapeutics, a subsidiary ... initiation of a Phase 2b dose-ranging study of AKCEA-APO(a)-L ... disease. The goal of the study is to determine ... Rx in a planned Phase 3 cardiovascular outcome ... of Akcea,s strategic collaboration with Novartis to develop and ...
(Date:3/30/2017)... DUBLIN , Mar 30, 2017 ... "Hemodialysis And Peritoneal Dialysis Market Size & Forecast, By Type ... (Home-based, Hospital-based), And Trend Analysis From 2014 To 2025" ... ... market is expected to reach USD 108.5 billion by 2025. ...
(Date:3/29/2017)... Research and Markets has announced the ... Forecast By Type (Insource IONM, Outsource IONM), By Region And ... offering. ... The global Intraoperative Neuromonitoring (IONM) market is expected to ... is anticipated to witness significant growth in the forecast period, ...
Breaking Medicine Technology:
(Date:3/30/2017)... ... 2017 , ... According to the American Society of Plastic Surgeons (ASPS), over ... top 5 most popular minimally-invasive cosmetic procedures in the country. With summer close, it’s ... the next 8-10 weeks. For anyone considering a hair removal procedure, there are a ...
(Date:3/30/2017)... ... March 30, 2017 , ... AudioEducator, ... conference “ Preventing Hospital Readmissions Through Discharge Planning ” with noted expert Sue ... ET. This conference discusses strategies to prevent readmissions in light of the most ...
(Date:3/29/2017)... ... March 29, 2017 , ... The Professional Squash ... has enlisted New York City-based sports and entertainment marketing firm Leverage Agency as ... opportunities for the Professional Squash Association (PSA), which includes first-time ever title sponsorship, ...
(Date:3/29/2017)... ... 2017 , ... Sublime Naturals and its founder, Kathy Heshelow, are big fans ... been used for thousands of years. , "The West has caught on, and has ... How to Use it For Your Wellness. Overcome Inflammation, Enemy of the Body. " ...
(Date:3/29/2017)... Indianapolis, IN (PRWEB) , ... March 29, 2017 ... ... Benefits Study, this webinar provides insight into the challenges employers face in trying ... the complexity of managing employee benefits programs? Adding to the growing complexity, ...
Breaking Medicine News(10 mins):