Founded by Yasamin Ameri, Former FDA Investigator and Compliance Officer, Cite2Close helps pharmaceutical, biotech, and combination product companies respond to Form 483 observations, resolve Warning Letters, and build inspection-ready quality systems.
Yasamin Ameri is the Founder & Principal Consultant of Cite2Close, bringing firsthand experience as an FDA Investigator with the Office of Inspections and Investigations (OII) and a Compliance Officer with CDER's Office of Manufacturing Quality (OMQ). Having conducted more than 150 inspections and evaluated Form 483 observations for violation classification — Official Action Indicated (OAI) or Voluntary Action Indicated (VAI) — from within the agency, she understands exactly what FDA expects — and applies that insider knowledge to help clients close the gap between where they are and where FDA expects them to be, with confidence.
Cite2Close was built to give regulated companies direct access to that insider perspective: practical, experience-based guidance that moves a company from citation to full closure and compliance, with clarity and confidence.
Cite2Close is supported by a team of former FDA investigators and compliance officers, bringing more than 50 years of collective FDA experience to every engagement.
Our former FDA investigators bring direct, field-inspection experience — conducting audits that identify the same gaps FDA investigators look for, before they become citations on a Form 483.
Our former CDER/OMQ compliance officers bring firsthand experience reviewing manufacturing quality records and data integrity (DI) issues at the compliance-officer level — the same lens FDA uses to evaluate whether a remediation is sufficient to close a case.
FDA issues a Form 483 when observed conditions at a site may violate GMP regulations. Your initial written response often determines whether the matter escalates to a Warning Letter. We help you draft initial and subsequent responses that directly address each observation with a risk assessment, credible root-cause analysis, a realistic corrective action timeline, and the documentation FDA looks for to close the loop.
A Warning Letter signals that FDA sees a pattern, not just an isolated issue — resolving it requires demonstrating systemic change, not just paperwork. We help you build a full remediation plan, coordinate corrective actions across departments, and prepare the documentation package that supports formal closure, tracking everything against FDA's specific concerns.
The best way to prepare for an FDA inspection is to go through one before it happens. We conduct realistic, investigator-style walkthroughs of your facility and documentation, flagging the same gaps an FDA inspector would — from equipment qualification to drug production processes and finished-product release — while there's still time to fix them.
Data integrity findings are among the fastest-escalating issues in an FDA inspection because they call into question the reliability of everything else in your records. We help you investigate the scope of the issue, remediate affected systems and procedures, and rebuild the ALCOA+ controls that demonstrate your data can be trusted going forward.
Many CAPA systems look complete on paper but fall apart under real scrutiny because they were built to satisfy an audit checklist rather than prevent recurrence. We help you design or rebuild CAPA and quality systems that hold up — with root-cause methodology, effectiveness checks, and documentation that would satisfy an FDA investigator.
A Consent Decree is a long-term commitment, often spanning years, with independent third-party auditors and strict reporting requirements. We help you navigate that process from the inside — coordinating with your independent auditor, preparing the periodic reports FDA requires, and keeping remediation work on track over the life of the decree.
An Import Alert can halt your product at the U.S. border. Getting removed requires demonstrating that the underlying issue has been resolved. We help you build the petition for removal, assemble the evidentiary package FDA requires, and manage the process through to resolution.
Sustainable compliance depends on your team, not just your systems. We provide targeted training for Quality, Manufacturing, and Regulatory staff — covering GMP fundamentals, FDA inspection readiness, documentation practices, and how to interact with an FDA investigator during an inspection. Sessions can be tailored to your specific citation history.
A deep-dive review of the citation, inspection history, and current quality systems to understand exactly what FDA found and why.
Build and implement corrective actions mapped directly to FDA's expectations — not generic fixes, but targeted responses to the actual finding.
Prepare final documentation and support you through FDA's review process, all the way through to formal closure.
