Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

FDA Warns Teva Over Manufacturing Issues

By Drug Discovery Trends Editor | April 28, 2010

NEW YORK (AP) – Federal regulators say Teva Pharmaceutical Industries Ltd.’s Parenteral Medicines unit failed to correct manufacturing problems at its Irvine, Calif. facility that caused contamination in batches of an anesthetic.

The Food and Drug Administration sent the Israeli generic drug developer a warning letter in December citing contamination with batches of pharmaceuticals made at the facility. The letter was posted on the agency’s Web site.

Teva said it continues to work with the FDA to address any concerns.

The FDA warned the company over a failure to correct issues with bacterial endotoxin contamination found in vials of propofol injectable emulsion, which is used as a general anesthesia. The lot was recalled.

“No corrective action was taken in response to this finding at the time of manufacture, and your firm released the lot,” the FDA said in the letter.

There were several other violations focusing on manufacturing the drug and contamination issues. Other violations observed during an inspection included a failure to subject lots to microbiological tests. The agency said the company failed to test each lot of raw materials used to make propofol injectable emulsion to determine the levels of bacterial contamination.

The agency also warned the company about a failure to clean and sanitize equipment and utensils at appropriate intervals to prevent contamination.

The FDA said the company “should take prompt action to correct the violations” and a failure to comply could result in legal action.

Teva said it has responded to the warning letter and moved its yearly plant shutdown to the last week in April from December “in order to more efficiently address process enhancements at the facility.”

Date: April 27, 2010
Source: Associated Press


Filed Under: Drug Discovery

 

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50