FDA Inspection Readiness and Regulatory Compliance—Led by Experience on Both Sides of the Inspection Table
FD-AID helps pharmaceutical, biologics, API, and regulated organizations prepare for FDA scrutiny, correct serious compliance failures, and build systems that remain defensible after the consultants leave.
When FDA Readiness Cannot Be Left to Guesswork
Inspection readiness is not a checklist exercise. FDA Investigators evaluate whether your procedures describe the work, whether your records demonstrate the work, whether your people understand the work, and whether management responds effectively when the system fails. FD-AID brings the perspective of a former FDA Investigator and pharmaceutical quality executive directly into that evaluation.
Inspection Readiness
Mock FDA inspections, pre-approval inspection support, surveillance and for-cause readiness, inspection backroom assistance, executive preparation, and site-specific training.
Remediation and Response
FDA Form 483 and Warning Letter responses, consent decree support, import alert remediation, investigations, CAPA, data integrity, quality-system recovery, and effectiveness verification.
Audits and Compliance
Supplier and vendor audits, sterile and nonsterile manufacturing assessments, laboratory and quality-system audits, BIMO support, risk assessments, and SOP development.
Experience That Changes the Conversation
FD-AID was founded by DeVaughn Edwards, who spent 14 years conducting FDA inspections before serving approximately 13 years in pharmaceutical Quality and Compliance leadership. His work has included sterile and nonsterile drug manufacturing, biologics, APIs, clinical investigations, remediation under significant FDA enforcement, and assignments across more than 20 countries.
The objective is not simply to prepare your organization to look ready. It is to determine whether your systems can withstand the questions, document requests, and follow-up analysis of an experienced FDA Investigator.
Regulatory Intelligence Built for Industry
Professionals who are not ready for a consulting engagement can access FDA-focused playbooks, audit tools, inspection-readiness resources, training, and enforcement analysis developed from real inspection and remediation experience.
Discuss Your Regulatory Risk Confidentially
Whether you are preparing for an announced inspection, responding to FDA findings, evaluating a vulnerable quality system, or planning proactive compliance work, the first step is a focused discussion of the risk, scope, and desired outcome.
FD-AID | FDA Inspection Readiness | Former FDA Investigator 