FDA records request support
Received an FDA records request or Form 483?
Turn scattered supplier records into an organized, inspectable response package. Work begins once scope and timing are confirmed in writing.
- Direct line: 202.344.7650
- Phone and email are monitored Monday–Friday, 10:00 a.m.–5:00 p.m. ET. Messages received outside these hours are answered as availability allows.
Our 3-step response-support workflow
A structured process to evaluate regulatory requests and organize your compliance files.
Situation assessment
Review official FDA communications, Form 483 observations, stated submission dates, and underlying facility records.
Gap analysis
Identify missing foreign supplier verification records, HACCP flowchart discrepancies, or preventive control gaps.
Response development
Compile, format, and organize technical compliance packages and formal response documentation for submission.
FDA situations we can review
FDA Form 483 observations
Document review and corrective action organization following routine or targeted importer inspections.
21 CFR 1.510 importer records requests
Organization and review of foreign supplier scorecards, hazard analyses, and verification activity logs.
Shipment detentions
Technical documentation organization to support an importer’s or supplier’s response to an FDA detention notice or an applicable Import Alert listing, within an agreed written scope.
Share the notice and stated dates
Describe the notice, its stated dates and the records you have. Include the FDA entry or detention number if there is one.
Contact details
- Phone
- 202.344.7650
- Office hours
- Monday to Friday, 10:00 a.m. to 5:00 p.m. Eastern Time
Contacting Clearance does not establish an engagement or confirm responsibility for a deadline. FSVP representation requires a separate eligibility review, written agreement, acceptance and signed consent.
Scope and limits
- Clearance first assesses whether the request fits the support available; an inquiry does not commit Clearance to response work or a deadline.
- FDA determines inspection findings and admissibility under the laws it administers. Clearance does not guarantee a particular inspection outcome, FDA approval or shipment release. Services are limited to the agreed written scope.