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Results for tag: "FDA Form 483"

FDA Warning Letter Closeout Program - Product Thumbnail Image

FDA Warning Letter Closeout Program

  • Training
  • 60 Minutes
  • Global
Changes in US FDA Enforcement - Product Thumbnail Image

Changes in US FDA Enforcement

  • Training
  • 90 Minutes
  • United States
Current Trends in FDA Inspections - Product Thumbnail Image

Current Trends in FDA Inspections

  • Training
  • 90 Minutes
  • Global
Cleaning & Cleaning Validation; an Overview - Product Thumbnail Image

Cleaning & Cleaning Validation; an Overview

  • Training
  • 60 Minutes
  • Global
CGMP controlled Raw Materials - Product Thumbnail Image

CGMP controlled Raw Materials

  • Training
  • 90 Minutes
  • Global
Implementing a Robust Data Integrity Program - Product Thumbnail Image

Implementing a Robust Data Integrity Program

  • Training
  • 90 Minutes
  • Global
Computer System Validation: Step-by-Step - Product Thumbnail Image

Computer System Validation: Step-by-Step

  • Training
  • 75 Minutes
  • Global
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The FDA Form 483 market is a subset of the pharmaceutical manufacturing industry. It is a regulatory document issued by the U.S. Food and Drug Administration (FDA) to a pharmaceutical manufacturing facility after an inspection. The form is used to document any observed violations of the FDA's Current Good Manufacturing Practice (CGMP) regulations. It is a critical tool for the FDA to ensure that pharmaceutical products are safe and effective. The FDA Form 483 market is composed of pharmaceutical manufacturers, contract manufacturers, and other related companies. Companies in this market include Pfizer, Merck, Novartis, GlaxoSmithKline, Sanofi, Johnson & Johnson, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly. Show Less Read more