Dec 21 2017

You Can – t Duct Tape Quality: FDA Issues Consent Decree against Actavis Totowa #pharmaceutical #industry #marketing

#actavis pharma manufacturing


Pharma Manufacturing

You Can t Duct Tape Quality: FDA Issues Consent Decree against Actavis Totowa

Submitted by pharmamanufacturing on Fri, 01/09/2009 – 12:48

In its neverending fight against both poor manufacturing practices and the manufacture and marketing of unapproved drugs, FDA has filed a Consent Decree and expects courts to prohibit Activis’ Totowa, New Jersey facility from further production.

Actavis Totowa—a subsidiary of Iceland-based generics maker Actavis, Inc.—manufactures, packages, and distributes drugs from two sites in Totowa and one in Little Falls, N.J. FDA inspected Totowa’s Riverview Drive facility early in 2008 and found that the company had significant cGMP violations and continued to manufacture unapproved drugs.

FDA has issued 483s to the facility based upon past inspections that revealed the company’s failure to investigate serious adverse event reports about some of its products, as well as a host of cGMP improprieties at the facilities including shoddy Quality Control and even one instance of, yes, duct tape being used to keep powder from leaking during production. In the summer of 2008, FDA forced the company to initiate a “voluntary” recall of all its products, from oxycodone to prenatal vitamins, as a precautionary action since the conditions under which the products were manufactured could not be verified as safe. As part of the Consent Decree, Activis must destroy any remaining recalled drugs still in its possession.

“The FDA will not allow manufacturers to put the public’s health at risk,” says Janet Woodcock, M.D. director of FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

The Decree also subjects the defendants, Activis, to pay $15,000 per day should they fail to comply with the provisions. The FDA will carefully monitor the provisions of this injunction to ensure compliance, says Michael Chappell, FDA acting associate commissioner in the Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Free Subscriptions

Most Popular

Novartis’ Alcon Penalized $16M for Illegal Exports to Iran

2016 Contract Pharma Trends Ebook

FDA OK’s Novartis Biosimilar to Amgen Arthritis Drug, Enbrel

Valeant Sued for Alleged Racketeering, Linked to Philidor

Novo Nordisk CEO Steps Down

2016 Contract Pharma Trends Ebook

Mylan Under Fire for Huge Price Hikes on More than Just Its EpiPen

Work for this Biotech Startup, Get a Free Tesla Car

FDA Warns China API Maker for Hiding Quality Testing Data

Innovation in Quality Metrics

Janssen’s Historic FDA Approval

2016 Contract Pharma Trends Ebook

Pfizer Might Have Takers for Struggling Hospira

On Solid Ground: Pharma’s Most Mature Dosage Form Endures

On the Cusp of Change

Weighing and Dispensing: Do it Right

Annual Product Reviews: How to Conduct an Effective Annual Product Quality Review

CAPA and Root Cause Analysis

USP Updates and for Microbial Testing of Non-Steriles

Reporting Failures and Process Deviations: A Closed-Loop Approach

Pharma Manufacturing




Site Tools

Stay Connected

Written by CREDIT

Leave a Reply

Your email address will not be published. Required fields are marked *