Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Inspection Of Genzyme Plant Finds Lack Of Follow-up, Old Equipment, Poor Personnel Qualification

This article was originally published in The Pink Sheet Daily

Executive Summary

A Form 483 posted online by FDA following a five-week inspection of the Allston Landing manufacturing plant cites 49 separate concerns.
Advertisement

Related Content

Replagal Advisory Committee Will Include Closed Door Session On Manufacturing
With Activist Investors Looming, Genzyme Takes Preventive Steps
With Activist Investors Looming, Genzyme Takes Preventive Steps
Genzyme To Contract Out Fill And Finish Responsibilities For Four Drugs To Hospira
Pfizer Thinks Small: Partnership With Protalix On Gaucher Drug Eyes Cheaper Plant-Based Production
Deals Of The Week: Pfizer/Protalix, AstraZeneca/Targacept, Chiesi/Phenomix
Pfizer Partners With Protalix On Gaucher Drug Eyeing Lower Cost Plant-Based Production
Continuing Allston Troubles Mean Another Brief Shutdown, Delay For Lumizyme Approval
Genzyme, FDA Warn Of Foreign Particles Found In Some Lots Of Five Drugs
Genzyme, FDA Warn Of Foreign Particles Found In Some Lots Of Five Drugs

Topics

Advertisement
UsernamePublicRestriction

Register

PS068821

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel