FDA-sourced Documents for Quality and Regulatory Teams.

Find FDA Form 483s, warning letters, guidance, and official forms in one place. Use published evidence to prepare for inspections, investigate quality issues, and support your regulatory reviews.

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Track

Explore FDA inspection activity, Form 483 observations, and warning letters to understand the issues raised with regulated companies.

Research

Search the FDA guidance library and read the official source documents relevant to your product, process, or regulatory question.

Prepare

Find FDA forms and templates by category. Open the original source to check the form and its instructions.

Find FDA records and reference documents.

Search, filter, and browse relevant records. Download available documents and follow links to official sources.

Inspection tracker

Explore global FDA inspection activity and trends to inform the areas your team wants to research.

Explore inspection activity

Warning letters

Review the issues FDA has raised with regulated companies. Read the source letters to understand the findings and their context.

Browse warning letters

Form 483s list with filters, observations, location and inspection date

FDA Form 483s

Read the inspection observations in their original context. Use relevant examples to inform internal audits and quality investigations.

Explore Form 483s

FDA guidance

Find guidance relevant to your product or regulatory questions. Open the official document to review its scope, status, and issue date.

Browse FDA guidance

Forms and templates list with official FDA documents

FDA forms and templates

FDA-sourced forms and templates by category, with links to the original documents and instructions.

Browse forms and templates

Bring stronger evidence to your team discussions.

Quality system heatmap of citation frequency by subsystem and quarter

For Quality Teams

Bring published FDA observations into inspection preparation, internal audits, and quality discussions.

Find inspection examples relevant to an investigation.
Use published findings to shape internal audit questions.
Bring real inspection examples into team training.

Explore inspection records

For Regulatory Teams

Build your research around the original FDA documents relevant to your product and regulatory questions.

Find guidance relevant to your product or process.
Check source documents for scope, status, and issue date.
Locate official forms for documentation and submission preparation.

Explore FDA guidance

Research the quality issues on your agenda.

Start with a process or concern your team is reviewing. Use these topics to guide searches across inspection observations, warning letters, and FDA guidance.

CAPA and investigationsReview examples involving root cause analysis, repeat deviations, corrective actions, and effectiveness checks. Data integrityExplore findings involving record accuracy, audit trails, data review, and access to original information. Process validationResearch validation evidence, qualification, process controls, and how manufacturing changes are assessed. Complaint handlingReview complaint evaluation, investigation records, recurring issues, and follow-up practices. Supplier qualityExamine supplier qualification, incoming material controls, quality oversight, and acceptance records. Manufacturing recordsResearch batch documentation, production instructions, record review, and traceability.

Start with inspection observations

Your questions about MyCQ.ai, answered.

What is MyCQ.ai?

MyCQ.ai is a free research resource from ComplianceQuest for quality and regulatory teams. It brings together FDA inspection information, Form 483s, warning letters, guidance, and official forms and templates.

Is MyCQ.ai free to use?

Yes. The current plan is completely free. Create an account with your email address to access the platform.

Can I access the original FDA documents?

Yes. Use the source links to read original documents, and download available files for your review.

Where do the forms and templates come from?

They are sourced from FDA and linked to the original source. Check the source page for the current version and instructions before using a form.

How can MyCQ.ai support inspection preparation and internal audits?

Use published FDA observations and warning letters to find examples relevant to your processes. These records can help your team prepare audit questions, identify areas to review, and build training around documented findings.

How can regulatory teams use MyCQ.ai?

Regulatory teams can locate FDA guidance relevant to a product or regulatory question, find official forms for documentation work, and review warning letters for context. Source links let you read the original material as part of your review.

What does the inspection tracker show?

The inspection tracker lets you explore global FDA inspection activity and trends, including information about inspections, Form 483 observations, and warning letters.

How is MyCQ.ai related to ComplianceQuest?

MyCQ.ai is a product by ComplianceQuest, created to provide useful research resources for quality and regulatory teams. You do not need to be a ComplianceQuest customer to create a free MyCQ.ai account.