About 483 Signal

483 Signal is an independent publication providing operational analysis of FDA drug manufacturing inspections.

What We Do

We analyze every FDA Form 483 observation and Warning Letter from drug manufacturing facilities, translating inspection findings into actionable operational insight for QA leaders, manufacturing managers, and process engineers.

Our analysis focuses on three questions:

  1. What actually happened? The factual breakdown of the inspection finding
  2. Why did it become a citation? The pattern or gap that triggered the observation
  3. What should you check internally? Practical steps for your own operation

What We Don't Do

  • No consulting services. We provide analysis, not remediation.
  • No vendor relationships. We don't sell software, training, or compliance tools.
  • No legal advice. We analyze inspection patterns, not regulatory strategy.

Who This Is For

483 Signal serves professionals who:

  • Manage GMP operations at biotech and CDMO facilities
  • Lead quality assurance and compliance programs
  • Make decisions based on inspection trends, not individual citations
  • Need operational context, not regulatory interpretation

Coverage

We cover every FDA drug manufacturing inspection finding since 2023, including:

  • Form 483 observations (all facility types)
  • Warning Letters (drug manufacturing only)
  • Consent Decrees (operational analysis)

Independence

483 Signal has no consulting services, no vendor partnerships, and no financial interest in compliance software or training programs. We make money one way: subscriptions.

This means our analysis serves readers, not business development. If we cover a finding that affects your operation, we explain what it means and what to check internally. We don't offer to fix it. We don't sell follow-on services.

Contact

For editorial questions, media inquiries, or technical issues: contact@483signal.com

For everything else, see our Contact page.

Disclaimer

483 Signal provides educational analysis of publicly available FDA inspection information. It does not provide legal or regulatory advice. All analysis represents independent commentary, not official guidance.