We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Troubled Fresenius Plant Upgraded by FDA

Troubled Fresenius Plant Upgraded by FDA

January 23, 2015

The FDA has upgraded its rating on Fresenius’ APP Pharmaceuticals New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm.

The plant, located in Grand Island, N.Y., was upgraded from official action indicated to voluntary action indicated. The FDA designates inspected facilities based on the quality observations it makes during inspection, with OAI being the most severe; VAI represents less significant quality problems.

Fresenius received the OAI status as the result of a 2012 warning letter that faulted the company for a litany of quality violations, including insects found in the manufacturing area during a 2011 inspection.

Fresenius was also chided for manufacturing unapproved prescription drugs. Fresenius did not elaborate on the changes it made to the facility to warrant the upgrade. But the company’s 2013 annual report shows that $42.5 million was paid in remediation costs at the Grand Island facility and a separate facility in Kalyani, India.

The India facility was warned in 2013 for serious data integrity violations, such as testing samples unofficially and not reporting all of the results obtained from those tests. Workers at the Kalyani plant also blended a batch of active pharmaceutical ingredient that had failed impurity tests with a batch that had passed in order to meet final impurity specifications, the letter says.

Fresenius did not return a request for comment by press time.

Stay up to date with breaking inspection stories like this one by subscribing to FDAnews Inspection Insider.

Drugs Inspections and Audits

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • GrayMatters Health’s Digital Therapy Device for PTSD Cleared

  • Dupixent Shows Positive Results in COPD Study

  • Advamedica’s Hemostat Cleared for Severe Surgical Bleeding

  • FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing