Use this button to switch between dark and light mode.

Responding to FDA Form 483 Inspectional Observations

July 01, 2025 (1 min read)

Check out this video discussing best practices for responding to FDA Form 483 inspectional observations.

Watch now »

Related Content

  • Life Sciences FDA Matters Representation and Warranty Clause
    Use this template to start drafting a compliance representation clause that the target has conducted its business in accordance with a series of specific laws, rules, and regulations governing the pharmaceutical industry as set forth by FDA and Medicare/Medicaid regulations.

Practical Guidance Updates
Featuring the latest updates from your Practical Guidance account.

  • What’s New in Practical Guidance
    Discover the newest Practical Guidance content and resources in  this update. This guide is designed to help you find the tools and insights you need to work more efficiently and effectively.
  • Review the Chevron Reversal Impact Resource Kit for analysis related to the Supreme Court’s decision to overturn four decades of deference to federal agency interpretations of ambiguous statutes.
  • New! Practical Guidance Journal, 2025 Second Edition features guidance for regulating AI in the workplace in 2025, Intellectual Property issues related to deepfakes, the emergence of AI in mergers and acquisitions, and a checklist to help when evaluating AI technology risks.
  • Browse the Practical Guidance Author Center to see the 2600+ leading attorney authors contributing to our 26 practice areas. Interested in becoming a Practical Guidance author? Click here for details. Practical Guidance is committed to amplifying diverse voices of attorneys across all differences, including gender and race.

PRACTICAL GUIDANCE CUSTOMER EMAIL EDITION ON THE WEB

Experience results today with practical guidance, legal research, and data-driven insights—all in one place.

Experience Lexis+