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 & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » ANDRX GETS NEW FORM 483

ANDRX GETS NEW FORM 483

April 28, 2006

The FDA has issued Andrx a new Form 483 after a reinspection of the drugmaker's Florida manufacturing plant, according to documents filed with the Securities and Exchange Commission (SEC).

Andrx said it would respond "promptly" to the observations the FDA made after its reinspection of Andrx's plant in March.

The FDA issued a Form 483 to Andrx in September 2005 after the agency found manufacturing violations at the drugmaker's Florida plant. The agency's Florida office then placed Andrx on Official Action Indicated status. As a consequence, all of Andrx's pending drug applications have been placed on hold.

"Resolution of the company's current Official Action Indicated (OAI) status is primarily dependent upon the FDA's review of the results of the inspection, which includes, among other things, the company's response to the observations," Andrx said in the SEC filing.

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

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

  • Hyris T-Cell Test Gains CE-IVD Mark

  • FDA Expands Approval of Bayer’s Nubeqa for Prostate Cancer

  • MicroPort Navibot Receives 510(k) Clearance for Its SkyWalker System

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing