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USFDA Registration, USFDA Inspection, USFDA Consultancy by USFDA Approved Consultant

USFDA Registration, USFDA Inspection, FSMA USFDA Compliance Audit Consultancy and USFDA Approved Consultancy by addwise

USFDA Registration is mandatory for all food business operators to export to USA any food product, dietary supplement, health supplement, cosmetic or drug product as per 21CFR USFDA.

USFDA has come out with FSMA (Food Safety Modernisation Act) to monitor import in US from Foreign Suppliers effective from January 2018. Monitoring, assessment and compliance would be implemented by FSPCA (Food Safety Preventive Control Alliance) through accredited agencies and accredited individuals like us called PCQI (Preventive Control Qualified Individual) USFDA FSPCA PCQI-2017.  

Who are affected ?

Food in any form, Food Ingredient, Food additives, Nutraceuticals, Food Supplement, Health Supplement, Dietary Supplements, Food for Special Medical Purpose, Sports Food, Ayurvedic Supplements or any other food supplements or food ingredients exporters to United State (US) market mandatorily needs to get registered with USFDA. These exporters are called Foreign Supplier and are subject to FSVP (Foreign Supplier Verification Program) implemented by FSPCA. These manufacturer exporters to US Markets must implement FSMA with their existing HACCP, ISO 22000, FSSC 22000, BRC Food, IFS or SQF systems and certifications.

All food, dietary supplements exporting to US of willing to export to US are subjected to USFDA registration and USFDA Inspection as per cGMP requirements laid down in 21CFR for USFDA registration and USFDA Inspection.

How addwise can help?

addwise being USFDA FSPCA Approved PCQI (Preventive Control Qualified Individual) USFDA FSPCA PCQI-2017 can assess your current manufacturing facility and documentation whether meeting FSMA compliance requirements as per 21CFR.

addwise can help consult and assist in preparing to comply with USFDA FSMA requirements for your food products. addwise being USFDA FSPCA Approved PCQI (Preventive Control Qualified Individual) USFDA FSPCA PCQI-2017 can certify and approve your existing Food Safety Management System Plan to submit to USFDA.

addwise can help you prepare for USFDA Registration, USFDA Inspection, FSMA Compliance and USFDA FSVP audits from USFDA by advising on infrastructure modifications, preparing customised documentation of your product/ process to meet USFDA Registration USFDA Inspection requirements and help implementing USFDA Inspection requirements through hand holding and trainings.

should you need more details please get in touch with us on or call us on +919978940673 – Girish Sharma.

Get one stop solution for any certification, compliance, advisory and training on FSSAI, USFDA, ISO 22000, BRC Food, FSSC 22000, IFS, SQF, HALAL, KOSHER, SEDEX certifications. Write to us on or call us on +919978940673 – Girish Sharma.