Welcome to FD-AID INTERNATIONAL Consulting

Premium Regulatory and Compliance Assistance

Who We Are

FD-AID, LLC Consulting provides PREMIUM technical, quality compliance and regulatory assistance with specific focus on the pharmaceutical industry. Created by a former FDA Investigator AND Pharma Industry executive, our goal is to assure you receive the best, tailored services. Knowing the needs from both sides of the aisle, we can help you retain or remediate regulatory compliance with measurable results. Using seasoned industry professionals and former FDA Investigators, the company has developed the capability to provide premium, efficient, compliance solutions to your specific problems, on time and right the first time.

Our mission is to provide outstanding technical and regulatory compliance assistance. We partner with our clients to assure immediate remediation, unmatched training and measurable improvements.

Work With Us

IF YOU WOULD LIKE A FULL LIST OF OUR SERVICES, PLEASE EMAIL US AT: FDAIDLLC@GMAIL.COM. WE LOOK FORWARD TO WORKING WITH YOU!

Our services include but is not limited to:

What Sets FD-AID Apart

FD-AID isn’t just another consulting firm—we’re a global FDA compliance force built on real-world inspection and remediation experience. Led by DeVaughn Edwards, a former FDA Investigator and former executive with multiple Big Pharma companies, FD-AID has:

  • Resolved over 600 FDA 483s and Warning Letter deficiencies,
  • Delivered compliance solutions in more than 25 countries,
  • And helped pharmaceutical and biological companies survive and recover from the types of inspections that shutter operations.
  • AND THE KEY…we always provide Quality Culture training to prevent deficiency recurrence! That means we initiate the good habits that become the culture that prevents going down the same wrong path. None of the Big Four consulting companies do that. Why? Because they want to keep coming back so that you keep paying for their cushy offices and exotic vacations.

We don’t just offer advice—we’ve been on the other side of the audit table. We know what the FDA is looking for because we’ve conducted the inspections. We’ve sat in executive war rooms during crisis remediation. We’ve rebuilt broken Quality Systems across continents.

When the stakes are high—FDA scrutiny, import alerts, site shutdown risks—FD-AID delivers experience, insight, and action plans that work.

Not sure what you need, or what it costs? We’re always happy to talk about how we can can work together. contact: devaughn@fdaid.org 732-895-7831

Train Smarter: FDA-Ready Tools and Trainings Created by Former Investigators

🔥 The FDA Inspection Hack Guide: Insider Tactics to Avoid 483s and Ace Every Inspection

I’ve partnered with the author of this hard-hitting book to raise awareness of this book!  It details what really happens during FDA inspections and how to have a great inspection experience. By the way, this isn’t sanitized guidance—it includes a scathing critique of FDA’s inconsistencies and gives you the insider tactics to survive your next audit. (Having spent half of my career in FDA, I can attest to many of the statements!)

👉 Buy the book on Amazon https://www.amazon.com/FDA-Inspection-Hack-Guide-Insider/dp/B0F9WLNX2K/ref=sr_1_1?crid=2V5ACYI2BEC2J&dib=eyJ2IjoiMSJ9.GdTlmTa48fVbog-3_YOSAg.CGWuws_VHNJqXSQXeuurFxbWDbleytT9t5Kcwx5rb8w&dib_tag=se&keywords=fda+inspection+hack+guide&qid=1751366366&sprefix=fda+in%2Caps%2C277&sr=8-1

💻 The FDA Inspection Masterclass (Video Download)

Stream or download this 45-minute masterclass designed to expose common GMP gaps—and show you how FDA actually thinks during audits.

Includes optional quiz + certificates.

👉 https://devaughn-edwards-s-school.teachable.com/purchase?product_id=6438110

🧪 Cleaning Validation – Direct-to-Site Zoom Training

Most cleaning programs don’t hold up under scrutiny. This live training (45–60 min) is available to your entire site, on your schedule, for $1200 flat.

Quiz + certificates included.

👉https://devaughn16.gumroad.com/l/fbpzjn

🔍 Need an On-Site or Virtual GMP Audit?

I perform mock FDA inspections and full GMP audits (drug or biologic) backed by 14 years with FDA and 13 years as a top executive with world renown pharmaceutical companies. Includes a report, executive debrief, and inspection readiness scoring. ASK ABOUT GMP CERTIFICATION!

👉https://devaughn16.gumroad.com/l/rukph

🛠️ Downloadable Audit Tools – Easy to Use, Hard to Ignore

Use these structured tools to train, audit, and correct before FDA shows up:

If your team hasn’t been trained by someone who’s actually stood in your facility as an FDA Investigator—now’s the time. These tools are designed to reduce the risk, raise internal standards, and protect your license to operate.

🎓 FDA INSPECTION MASTERCLASS

Learn Directly From a Former FDA Investigator and Pharmaceutical Executive

https://devaughn-edwards-s-school.teachable.com/p/fda-inspection-master-classhttps://devaughn-edwards-s-school.teachable.com/p/fda-inspection-master-class

Are you ready for your next FDA inspection—or will it shut down your operation?

With over 35 years of combined experience as a former FDA Investigator and senior executive at leading pharmaceutical manufacturers, I created this FDA Inspection Masterclass to give you the same insights I’ve provided to companies across 29 countries. This training is used to prepare drug manufacturers, biologics firms, and international suppliers for real inspections—often after receiving a 483 or Warning Letter.

This isn’t theory. This is what you must know to survive and succeed during an FDA inspection.

✅ What You’ll Learn:

  • The top mistakes companies make during FDA inspections—and how to avoid them
  • What the FDA really looks for (that SOPs don’t always cover)
  • The difference between a “compliant response” and a “corrective response”
  • Real-world examples of what causes 483s and Warning Letters
  • How to prepare your team and facility to pass confidently

🧪 Who This Course Is For:

  • Pharmaceutical Quality Leaders
  • Regulatory Affairs Managers
  • Site Heads and Manufacturing Directors
  • Clinical and CDMO Partners
  • Anyone facing an upcoming FDA inspection

📹 Course Format:
44-minute video packed with real-world insights, strategic preparation tools, and FDA field experience.

💼 Instructor:
DeVaughn Edwards
Former FDA Investigator | Sr. Director of Compliance (J&J, Lonza) | Founder of FD-AID, LLC

👉 Buy now

🛡️ Be ready before the FDA walks through your door. Your license depends on it.
📧 For group licensing or inquiries, contact me directly at devaughn@fdaid.org or call 732-895-7831.

🚨 Now Offering Direct Site Training on Cleaning Validation 🚨

Are your teams ready to defend their cleaning validation program in an FDA inspection?

FD-AID, LLC is now offering LIVE, site-specific virtual training for just $1,200 USD—with no cap on attendee size!

✔️ 45-minute to 1-hour session (training + live Q&A)
✔️ Unlimited participants from your site
✔️ Includes a knowledge assessment quiz
✔️ Certificates of completion for all attendees

This is practical, regulatory-grade training—developed and delivered by a former FDA Investigator and pharma industry executive.

🔗 Book your session now: devaughn16.gumroad.com/l/fbpzjn

Ask the FDA Experts! – FD-AID Compliance Q&A Service

Are you a pharmaceutical or biological company seeking expert advice on regulatory and compliance matters? FD-AID, LLC offers a seamless “Ask the Experts” service, providing you with accurate, actionable answers from seasoned professionals, including a former FDA Investigator and pharmaceutical industry executive.

How It Works:

Download and Complete the Submission Document: https://fdaid.org/wp-content/uploads/2024/11/fd-aid-consultation_document-2.docx
Start by downloading the attached submission document here. This document provides a clear format for submitting your questions. Ensure your question is specific, clear, and includes all relevant details to enable us to provide a precise response. If your question requires supporting information or documentation, include those as attachments in the file formats outlined in the document.

Submit the Document:
After completing the form (https://fdaid.org/wp-content/uploads/2024/11/fd-aid-consultation_document-2.docx), email it to us at fdaidllc@gmail.com.

Make a Payment:
The fee for each question is $100. Submit your payment via PayPal to fdabox@gmail.com. Payments must be made prior to receiving a response.

Receive a Tailored Response:
Upon confirmation of payment, our experts will review your submission and provide a comprehensive, confidential response. This response will include analysis, recommended actions, and resources for further guidance.

Confidentiality Assurance:
We understand the sensitivity of your inquiries. All information submitted to FD-AID, LLC through this service will remain strictly confidential and will only be used for the purpose of responding to your question.

Disclaimer:
The information provided through this service is intended for informational and educational purposes only and does not constitute legal or professional advice. Users are encouraged to consult a professional for tailored guidance. FD-AID, LLC shall not be liable for decisions made based on the information provided.

Ready to Submit Your Question?

Download the submission document. https://fdaid.org/wp-content/uploads/2024/11/fd-aid-consultation_document-2.docx
Email your completed form and attachments to fdaidllc@gmail.com.
Pay via PayPal to fdabox@gmail.com

Enhance Your Audits with Expert-Guided Tools

FD-AID, LLC is proud to offer a series of comprehensive audit tools, designed by former FDA Investigators to support pharmaceutical professionals in conducting thorough and effective audits. These resources provide a structured approach to evaluating compliance, identifying risks, and ensuring adherence to FDA regulations and industry best practices.

Explore Our Audit Tools:

1. The Ultimate Clinical Audit Tool: Insights from Former FDA Investigators

Available on Amazon

This essential guide provides a detailed framework for auditing clinical trial sites, ensuring compliance with Good Clinical Practice (GCP) regulations and FDA expectations. Key features include:

  • In-depth assessment criteria for clinical site inspections
  • Common deficiencies and how to verify compliance
  • Guidance on documentation, informed consent, and data integrity
  • Strategies to mitigate risk and ensure trial integrity

2. The Ultimate Solid Oral Dose Audit Tool: Insights from Former FDA Investigators

Available on Amazon

A must-have for professionals auditing solid oral dosage manufacturing facilities, this tool provides:

  • Step-by-step audit checklists covering all aspects of production
  • Common regulatory pitfalls and how to address them
  • Key compliance areas, including equipment qualification, cleaning validation, and batch record review
  • How to prepare for an FDA inspection and avoid 483 observations

3. The Ultimate API Audit Tool: Insights from Former FDA Investigators

Available on Amazon

Focused on Active Pharmaceutical Ingredient (API) manufacturing, this tool provides:

  • Comprehensive coverage of Good Manufacturing Practice (GMP) compliance
  • Critical audit points for raw materials, processing, and stability testing
  • Detailed guidance on impurity control, data integrity, and supplier qualification
  • Real-world case studies and enforcement trends

Why Use These Tools?

✔ Developed by Former FDA Investigators – Leverage insights from experts with firsthand regulatory experience.
✔ Structured, Practical, and Easy to Use – Designed for industry professionals conducting audits.
✔ Proactively Identify & Mitigate Risks – Stay ahead of compliance challenges and avoid regulatory pitfalls.
✔ Improve Regulatory Readiness – Strengthen your company’s preparedness for FDA inspections and global compliance expectations.

🔎 Get Your Copy Today! Purchase directly from Amazon using the links above. Stay ahead in compliance and ensure audit success!

For consulting support, training, or additional resources, contact  devaughn@fdaid.org   or fdaidllc@gmail.com or book directly online! https://devaughn16.gumroad.com

Quality Systems Certification™ by FD-AID, LLC

Proactive Solutions for Pharmaceutical Quality and Compliance

In today’s stringent regulatory environment, marked by increased FDA enforcement actions such as Warning Letters and FDA-483s, pharmaceutical companies must prioritize robust Quality Systems. FD-AID, LLC proudly offers the Quality Systems Certification™ program, a proactive and strategic initiative designed to help companies enhance their compliance framework and address potential deficiencies before they escalate into regulatory findings.

About the Quality Systems Certification™ Program

Launched in January 2023, this certification program provides an independent, third-party review of pharmaceutical operations under dynamic conditions. The program is designed to assess and certify compliance across the six key Quality Systems recognized by the FDA:

  1. Quality
  2. Production
  3. Facilities and Equipment
  4. Laboratory Controls
  5. Materials
  6. Packaging and Labeling

Certification Requirements
To achieve certification, companies must undergo a rigorous on-site audit overseen by at least one former FDA Investigator with subject matter expertise in the system(s) being audited. Certification is contingent upon the following:

  • Zero Major or Critical deficiencies observed during the audit.
  • If any such deficiencies are identified, evidence of successful closure through the site’s CAPA procedures must be reviewed and approved prior to certification issuance.

What Sets FD-AID Apart?

More than 95% of pharmaceutical companies that receive FDA Warning Letters hold ISO certification. Why? Because ISO does not perform FDA inspections or use the same methodology as the FDA.
Unlike ISO, FD-AID harnesses the inspection knowledge and methods of actual former FDA Field Investigators. Our expertise ensures that your organization is prepared to meet FDA’s stringent requirements—not just ISO standards. This critical distinction can make the difference between compliance success and enforcement action.

Benefits of Certification

  • Pre-Inspection Readiness: The certification helps companies proactively address potential deficiencies before an FDA inspection.
  • Post-Inspection Remediation: It can also be integrated into a remediation plan following an FDA inspection.
  • Targeted Scope: Companies can select specific Quality Systems to be audited or choose a comprehensive review.

Global Reach

Since its inception, the program has served pharmaceutical manufacturers worldwide. The kick-off audit commenced on January 18, 2023, in India. FD-AID anticipates expanding this program to companies across the U.S., Africa, Europe, and Asia.

Why Choose FD-AID, LLC?

FD-AID is a trusted pharmaceutical consulting agency founded by DeVaughn Edwards, a former FDA Investigator with over a decade of experience. The team consists of former FDA Investigators and seasoned pharmaceutical industry executives, bringing unparalleled expertise to your organization. In less than three years, FD-AID has successfully completed over 100 projects across 9 countries, establishing itself as a global leader in quality and compliance consulting.

Contact Us Today to Learn More
Email us at fdaidllc@gmail.com, devaughn@fdaid.org, or devaughn@gmail.com to discuss how FD-AID’s Quality Systems Certification™ program can support your compliance and operational excellence goals.

NEW! FD-AID ACADEMY ON-DEMAND TRAINING

FD-AID is now providing on-demand GMP training. This platform will enable anyone within the pharmaceutical industry to access training on a variety of topics from any device at any time! We are initiating this new platform with Annual GMP Training, which is a Federal Regulatory requirement for the pharma industry. This training is provided free (!) for pharmaceutical professionals. We do ask that you donate to maintain this, and potentially other, training modules free.

The training can be accessed at this link:  https://youtu.be/0gUMOszEpw0

FDA Clinical audit tool  

Introducing the Clinical Audit Tool – Designed by Former FDA Investigators
Price: $149  devaughn16.gumroad.com/l/hlmer

Are you ready to elevate your compliance strategy and conduct audits like the experts? Look no further. The Clinical Audit Tool is your ultimate resource, meticulously crafted with insights from former FDA Investigators. This tool is tailored to provide you with a clear and comprehensive framework to perform audits with the precision and focus of an FDA inspection. devaughn16.gumroad.com/l/hlmer

Why Choose the Clinical Audit Tool?

  • FDA Expertise Built-In: Developed using the knowledge and experience of seasoned FDA Investigators who have conducted countless inspections. This tool captures their methodologies, priorities, and insights to ensure nothing gets overlooked.
  • Focus on Key Inspection Areas: The tool highlights critical elements that Investigators typically target, from clinical trial documentation to investigator site management and regulatory compliance.
  • Identify Common Deficiencies: Gain insight into frequent gaps and deficiencies that have led to findings in FDA inspections. Use this knowledge to proactively address vulnerabilities in your clinical operations.
  • Structured and User-Friendly: Follow a logical, step-by-step approach that mirrors the FDA inspection process, making it simple to integrate into your quality assurance program.

Features of the Clinical Audit Tool:

  1. Comprehensive Audit Checklist: Covering all major areas of clinical compliance, including protocols, informed consent processes, data integrity, and investigational product management.
  2. Risk Assessment Guides: Tools to help you evaluate and prioritize areas of highest compliance risk.
  3. Inspection-Ready Tips: Practical advice on preparing for FDA inspections and maintaining a state of readiness.
  4. Customizable Templates: Tailor the tool to your specific clinical operations or audit requirements.

Benefits of the Clinical Audit Tool:

  • Enhance your internal audit program with an FDA-centric perspective.
  • Minimize risk by identifying and addressing compliance gaps before inspections.
  • Build confidence in your clinical teams with a systematic and proven approach.
  • Protect your research and reputation by ensuring regulatory compliance.

Who Is It For?

The Clinical Audit Tool is ideal for:

  • Sponsors of clinical trials
  • CROs and quality assurance teams
  • Clinical trial sites
  • Compliance professionals looking to strengthen their audit processes

Invest in your compliance success today. At just $149, this tool offers immense value for any organization committed to excellence in clinical trial operations.

Order Now  

and gain the confidence to approach every audit and inspection with clarity and control.

Don’t wait—equip your team with the knowledge and tools of FDA experts today!

Give us a call or reach out by email — let’s start the conversation. Ask about our Executive’s Assistance (Coaching for Executives) service!

Get in Touch

FD-AID, LLC
Lutz, Florida
devaughn@fdaid.org, fdaidllc@gmail.com, devaughn@fdaid.org

(732) 895-7831

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