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FDA Registration
US FDA facility registration and Prior Notice for food, cosmetics, and medical device exporters to the United States. Expert guidance through FDA registration requirements.
US FDA
US FDA 21 CFR
US FDA 21 CFR
FDA
What is US FDA Facility Registration?
The US FDA (Food and Drug Administration) requires food facilities, cosmetic manufacturers, and medical device companies exporting to the USA to register their facilities and comply with relevant 21 CFR regulations. CAS supports Egyptian and regional manufacturers through the FDA registration process via established US regulatory affairs partners.
Who Is This For?
Food manufacturers, cosmetics producers, pharmaceutical companies, dietary supplement manufacturers, and medical device producers wishing to export products to the United States market.
Key Benefits
- Required for all food and medical device exports to the USA
- Guidance from experienced US regulatory affairs specialists
- Covers FSVP (Foreign Supplier Verification Program) requirements
- Prior Notice filing support for food shipments
- Ongoing compliance monitoring and renewal support
- Combined with ISO 22000 / FSSC 22000 for full food safety compliance
Certification Process
1
Application & Review
Submit your application. CAS reviews your organisation's scope, personnel, sites, and activities to prepare a detailed audit time calculation and formal commercial proposal.
2
Stage 1 — Document Review
On-site or remote review of your management system documentation, readiness assessment, and confirmation of Stage 2 audit scope and plan.
3
Stage 2 — On-site Audit
Full on-site audit of the implemented management system against the standard's requirements. Findings are reported; nonconformities must be closed before certification.
4
Certification Decision
CAS's independent certification committee reviews the audit findings and issues the certificate. The certificate is valid for 3 years.
5
Surveillance & Recertification
Annual surveillance audits (~1/3 of initial audit time) maintain certification. Recertification audit (~2/3 of initial time) is conducted before certificate expiry to renew for a further 3 years.
Frequently Asked Questions
Yes. Under the FDA Food Safety Modernization Act (FSMA), all food facilities that manufacture, process, pack, or hold food for human or animal consumption in the US must register with the FDA.
Prior Notice is the FDA requirement to notify them before food shipments arrive in the US. CAS can assist with Prior Notice filing through our regulatory affairs partners.
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