Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Mylan, FDA Disagree on Quality Control Inquiry

By Pharmaceutical Processing | July 28, 2009

NEW YORK (AP) — Generic drug developer Mylan Inc. said Tuesday the FDA backed up the company’s position that employees at a West Virginia facility did not ignore quality control procedures, though the agency disputes the company’s claim. Mylan said FDA investigators found that claims in a lengthy investigative piece by the Pittsburgh Post-Gazette were unfounded. The agency, though, said that was not the case and the FDA has yet to form a conclusion. Any statement implying so, is “untrue,” the agency said. “The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue,” said Steven Solomon, the agency’s assistant commissioner for compliance policy. He said the investigation involves “allegations of compliance violations that the FDA takes very seriously.” On Sunday, the Pittsburgh Post-Gazette published an article saying the company discovered workers routinely ignored warnings about potential problems in the production process at a Morgantown, W.Va. facility. Mylan shot back with a statement the same day disputing the article. Mylan said FDA officials visited the facility Monday after the company’s “proactive” contact and noted there was no evidence of any data deletion in regard to the quality controls. “All data was reviewed and was present and accounted for; the agency agreed that this was a minor standard operating procedure deviation that existed, was fully investigated, and all corrective actions were fully implemented by Mylan,” the company said in a statement.

Related Articles Read More >

Pfizer logo
Pfizer seeks to comply with voluntary Net-Zero Standard by 2040
Fujifilm Diosynth Technologies
Fujifilm to spend $1.6B to bolster cell culture manufacturing services
Wyzo
Wyzo high-speed pick-and-place sidebot wins design awards
Purdue University
Purdue University launches institute for advanced manufacturing of pharmaceuticals

DeviceTalks Tuesdays

DeviceTalks Tuesdays

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 Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

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 Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards