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 » Wyeth to Answer FDA Reinspection Findings in Guayama Facility

Wyeth to Answer FDA Reinspection Findings in Guayama Facility

April 13, 2007

Wyeth will respond this month to Form 483 observations from an FDA reinspection of the company's Guayama, Puerto Rico, manufacturing facility, the firm announced.

The agency cited Wyeth last year for current good manufacturing practice (cGMP) violations at the Guayama site in a warning letter.

The company "intends to respond in writing to the observations issued by the FDA inspector no later than mid-April and then will seek to continue its discussions with the agency regarding the overall compliance status of the facility," Wyeth said.

Wyeth also said the discrepancies cited by the agency in the reinspection involved sampling and testing procedures, as well as review of lab and process investigations. The agency conducted the reinspection between late January and late March.

Resolution of the manufacturing issues is, in part, holding up approval of the antidepressant Pristiq, according to an FDA approvable letter Wyeth received for the Effexor follow-on earlier this year.

However, Wyeth noted that a European Medicines Agency (EMEA) inspection of the Guayama site last month found "no critical or major observations." The EMEA gave the site a positive evaluation for compliance with cGMPs, the firm said.

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

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

  • NeuroMetrix Launches DPNCheck 2.0 for Peripheral Neuropathy Screening

  • Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate

  • FDA Approves Abbott’s Spinal Cord Stimulation System for Diabetic Peripheral Neuropathy

  • FDA Expands Approval for Merck’s Keytruda in NSCLC

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