Navigation Links
Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give up $175 Million in Profits
Date:5/24/2010

sorders. During an inspection of the Allston plant from Oct. 8, 2009, until Nov. 13, 2009, FDA inspectors found that the company's systems for ensuring manufacturing quality were inadequate resulting in production delays, critical shortages of medically necessary products to consumers and drugs contaminated with metal, fiber, rubber and glass particles. These manufacturing problems violated the FDA's regulations for manufacturing practice. Genzyme also temporarily suspended manufacturing of some products due to a viral contamination in a bioreactor that makes bulk amounts of its drugs. This resulted in additional drug shortages.

"It is critical for the safety of the drug supply that companies comply with basic manufacturing standards. FDA takes these obligations very seriously and expects manufacturers to do the same," said Joshua Sharfstein, M.D., FDA principal deputy commissioner.

Cerezyme, Fabrazyme, Myozyme, and Thyrogen are drug products that undergo all or some stages of manufacture at the Allston plant. Cerezyme treats Gaucher's disease, which causes fatty substances to accumulate in the liver, spleen and other organs. Fabrazyme treats Fabry disease, which prevents the body from breaking down oils and fats that build up in the eyes and the kidneys. Myozyme treats Pompe disease, a muscular disorder, and Thyrogen is used to diagnose thyroid cancer.

Genzyme has agreed to a work plan for making facility improvements. It begins with selecting, within 10 days of entry of the decree by the court, an independent expert who will inspect the plant and issue recommendations. Genzyme will use the expert's recommendations to create a work plan, subject to FDA approval, that requires specific steps for bringing its '/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
2. Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis
3. Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
4. Genzyme Corporation Selects Diplomat Specialty Pharmacy for 2008 Renagel Medicare Part D Assistance Program
5. Genzyme Announces Presentation of New Positive Data on Carticel(R)
6. Genzyme Genetics Announces Launch of Carrier Testing and Prenatal Diagnosis for Spinal Muscular Atrophy
7. Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
8. Genzyme and Isis Complete Licensing of Mipomersen
9. Genzyme and Isis Begin Second Phase 3 Trial Of Mipomersen
10. Pain Relief in Just One Visit with Genzymes Synvisc-One
11. Webcast Alert: Isis Pharmaceuticals and Genzyme Corporation to Present Mipomersen Phase 3 Data in HoFH During AHA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... April 17, 2015  Trovagene, Inc., (NASDAQ:  TROV) ... that clinical data presented at the 2015 European ... Precision Cancer Monitoring ℠ (PCM) platform outperformed ... EGFR T790M mutations in metastatic lung ... EGFR T790M Mutation in Urinary Circulating Tumor DNA ...
(Date:4/17/2015)... 17, 2015 Steven Rash , the CEO ... its operating subsidiary American Seed & Oil Company, presented ... investors yesterday in New York City.  Mr. Rash,s presentation ... American Seed & Oil Company has recently announced the ... Hemp Seed Foods , the EpiVape , and ...
(Date:4/17/2015)... , Apr. 16, 2015 Research and Markets ... of the "Corporate Reputation of Pharma in 2014 ... 1st Edition" report to their offering. ... compared opinions on the corporate reputation of the pharmaceutical ... mental health with the views of patient organisations representing ...
Breaking Medicine Technology:Trovagene's Urinary ctDNA Assay Outperforms Tissue Biopsy in Clinical Study for the Detection of EGFR T790M Mutations in Metastatic Lung Cancer Patients 2Trovagene's Urinary ctDNA Assay Outperforms Tissue Biopsy in Clinical Study for the Detection of EGFR T790M Mutations in Metastatic Lung Cancer Patients 3Trovagene's Urinary ctDNA Assay Outperforms Tissue Biopsy in Clinical Study for the Detection of EGFR T790M Mutations in Metastatic Lung Cancer Patients 4American Seed & Oil Company Benchmarks its Consumer Product Development Strategy Against Proctor & Gamble 2American Seed & Oil Company Benchmarks its Consumer Product Development Strategy Against Proctor & Gamble 3Corporate Reputation of Pharma in 2014 - The Perspective of Mental Health Patient Groups - 1st Edition 2Corporate Reputation of Pharma in 2014 - The Perspective of Mental Health Patient Groups - 1st Edition 3
... 23, 2011 Dr. Michael Hayden, a Xenon founder ... Wightman Award for leadership in medical science in Canada. ... for Dr. Hayden, having previously been awarded the Order ... Institutes of Health Research,s Health Researcher of the Year ...
... 22, 2011 Boston Scientific Corporation (NYSE: BSX ... on April 4, 2011 at the 60th Annual Scientific Session ... The Company will provide an update on its Cardiology, Rhythm ... heart technologies.  The event is scheduled to begin at 6 ...
Cached Medicine Technology:Xenon Chief Scientific Officer, Dr. Michael Hayden Receives Prestigious Award for Leadership in Medicine 2
(Date:4/19/2015)... Indiana (PRWEB) April 19, 2015 ... statewide Network Service Provider, announces a major bandwidth ... (AdamsWells) in Bluffton, IN. Craigville Telephone Company, ... has expanded service on IFN’s protected 10 Gigabit ... Zehner, IFN’s Vice President of Sales and Marketing, ...
(Date:4/18/2015)... CA (PRWEB) April 19, 2015 For some ... will proudly display for the rest of their lives, as ... obtaining them and put in a great amount of thought ... a whim, they have outgrown them or simply want them ... of people regret their tattoo, and in 2012-13 there was ...
(Date:4/18/2015)... Carinsurancequotesinfo.com has released a new blog post ... caused by a car accident. , Car ... vehicle. A policy can pay for car repairs and ... always carry appropriate coverage when they are driving. ... with several important riders that offer extra coverage options. ...
(Date:4/18/2015)... 18, 2015 "I recognized the need ... healthcare facilities," said an inventor from Cincinnati, Ohio. "This ... , He developed the Slyde Door to offer an ... healthcare facilities. It provides convenient storage space for an ... stretchers available for patients. , This offers added ...
(Date:4/18/2015)... Insuranceautoquote.info has released a new blog post explaining how ... , Clients can review important auto insurance quotes online, ... important advantages for clients who need affordable financial security ... have coverage for their vehicles can purchase a policy ... Many agencies offer important discounts and drivers can learn ...
Breaking Medicine News(10 mins):Health News:AdamsWells Internet Telecom TV Expands Bandwidth via Indiana Fiber Network, LLC 2Health News:Dennis Dass, M.D. is Shattering the Past While Revealing the Future 2Health News:Auto Insurance Plans Can Cover Physical Injuries Caused By An Accident! 2Health News:Clients Can Review Car Insurance Quotes Online To Find Low Cost Offers! 2
... to reduce transmission from mother to child, experts say ... HIV infection in infants are significantly higher among blacks ... to reduce the disparity, a new government report says. ... overall, among black babies, the rate of perinatal HIV ...
... , SACRAMENTO, Calif. , Feb. 4 ... CEO and Meg Heim, RN , Vice President of Marketing ... Force Committee on behalf of the Governor of California , ... California Department of Chronic Disease and Injury Prevention (CDPH).  The committee ...
... , ATLANTA , Feb. 4 ... Financial Management Association (HFMA) performed a rigorous assessment of ... by Surgical Information Systems, and determined that it meets ... the areas of effectiveness, quality and usability, price, value, ...
... , HAMILTON, Bermuda , ... ("XL" or the "Company") today announced that Chief Executive,Officer Michael S. ... 2010 at the Mandarin Oriental Hotel in Miami, Florida ,on ... A live webcast of Mr. McGavick,s presentation will ...
... , , EDF Testifies 20 Million+ Residents in South ... Calif. , Feb. 4 Environmental Defense Fund ... Standard (NAAQS) for ozone pollution from 75 to 60 parts ... reduce asthma cases 50-fold, according to analyses by the Environmental Protection ...
... (Feb. 4, 2010) Patients with mild gallstone pancreatitis usually ... symptoms to subside, before undergoing surgery to remedy the condition. ... Institute (LA BioMed) indicates patients may no longer have to ... sooner. The study, slated for publication in the ...
Cached Medicine News:Health News:Black and Hispanic Infants Much More Likely to Have HIV 2Health News:BioMedix Vascular Solutions, Inc. Invited to Participate in the California P.A.D. Task Force Committee 2Health News:SIS Rules-Based Charging Solution Successfully Peer Reviewed by HFMA for Third Consecutive Year 2Health News:SIS Rules-Based Charging Solution Successfully Peer Reviewed by HFMA for Third Consecutive Year 3Health News:XL Capital Ltd to Present at Credit Suisse Financial Services Forum on February 11, 2010 2Health News:Stronger Ozone Standard Could Dramatically Reduce Asthma, Premature Deaths 2Health News:Stronger Ozone Standard Could Dramatically Reduce Asthma, Premature Deaths 3Health News:Patients with mild gallstone pancreatitis can undergo surgery sooner, shortening hospital stays 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: