FDA Compliance Services & Digital Resources
Need FDA regulatory assistance that is not included in our standard service-fee listings? U.S. FDA Consultants can provide customized compliance support for domestic and foreign manufacturers, exporters, importers, distributors, e-commerce sellers and other companies handling FDA-regulated products.
Many specialized projects require an evaluation of the product, establishment, regulatory history and scope of work before a service fee can be determined. Contact us for a customized quotation.
Extended FDA Compliance Services
The following regulatory services can be provided on a customized basis when they are not already included within another registration, compliance or annual service package.
FDA Inspection Readiness
Preparation assistance for manufacturers and establishments expecting an FDA inspection, including documentation review, inspection-response preparation and identification of potential compliance gaps.
Mock FDA Inspection
Simulated inspection and compliance review designed to help establishments prepare personnel, records, procedures and facility documentation before regulatory inspection.
FDA Warning Letter Assistance
Regulatory consulting for companies reviewing FDA Warning Letters, inspection observations or other compliance correspondence and preparing an appropriate corrective response strategy.
FDA Detention Assistance
Assistance reviewing FDA holds, detentions, entry documentation and regulatory compliance issues affecting imported FDA-regulated products.
FDA Label Review
Review of food, dietary supplement, cosmetic, OTC drug, prescription drug or medical-device labeling based on the applicable regulatory category and scope of work.
Food Safety Plan Development
Customized assistance with food safety documentation, hazard evaluation, preventive controls, monitoring, corrective-action and verification records.
HACCP Plan Development
Assistance developing or reviewing Hazard Analysis and Critical Control Point documentation for products and facilities where HACCP requirements or customer expectations apply.
FSVP Program Development
Development, review and maintenance support for Foreign Supplier Verification Program records, supplier documentation, hazard analysis and verification activities.
FDA SOP Development
Customized standard operating procedures for regulatory records, complaints, recalls, supplier verification, document control and other FDA-related compliance functions.
FDA Compliance Audit
Independent review of regulatory registrations, listings, labels, import documentation and compliance procedures to identify areas requiring attention.
Amazon U.S. FDA Compliance
Streamline your U.S. product launches with expert FDA regulatory support for Amazon FBA and third-party logistics (3PL) centers.
Customized Regulatory Consulting
Project-specific support for manufacturers, exporters, importers and distributors facing FDA registration, labeling, import, inspection or compliance questions.
FDA Compliance E-Books & Digital Resources
Expand your regulatory knowledge with practical digital resources designed for companies, employees and professionals involved with FDA-regulated products.
Master FDA Inspection Readiness
A practical digital resource focused on preparation for FDA inspections and inspection-readiness considerations for FDA-regulated establishments.
FDA Food Flash Cards
Quick-reference digital flash cards designed to support learning and review of FDA food compliance concepts.
Ultimate FDA Compliance Guide for Facebook Sellers
A digital guide created for online sellers navigating FDA compliance considerations when marketing and selling FDA-regulated products through Facebook.
FDA Compliance Support for Global Companies
Regulatory consulting services are available to domestic U.S. businesses as well as foreign companies manufacturing, exporting, importing or distributing FDA-regulated products destined for the United States.
Need Help With U.S. FDA Compliance?
Whether you need assistance with FDA registration, product listing, labeling, inspection readiness, FSVP, food safety, import compliance, detention assistance, establishment documentation or another regulatory requirement, contact U.S. FDA Consultants to discuss your project.
If the service you are seeking is not listed, send us the details of your request and the FDA-regulated product involved. Customized regulatory services can be evaluated according to the scope of work.
Email: info@itbholdingsllc.com
Service fees for customized regulatory projects depend on the product category, establishment, documentation, regulatory history and scope of work. Consulting services are independent professional services and do not constitute FDA approval, certification or endorsement.