US Supplement Compliance & FSVP Oversight
Budget / SalaryHourly project
TypeFreelance project
LocationRemote
Posted1 hour ago
I import and distribute dietary supplements in the United States and need a qualified US-based compliance partner who can take charge of three critical tasks under my direction: continuous FSVP monitoring, thorough supplement label review, and timely customs pre-notification for every shipment arriving at port or airport.
Your background must include hands-on experience with FDA Supplements Label Review, FSVP Monitoring, and Customs Prenotification. Please reference specific brands, SKUs, or importers you have supported so I can see the depth of your expertise. Familiarity with 21 CFR 101, DSHEA, Prop 65, the FDA PREDICT system, and the ACE portal is expected; PCQI or FSVP QII credentials would be a welcome bonus.
Scope of work
• Monitor and maintain complete, auditable FSVP records for each foreign supplier—hazard analyses, verification activities, corrective actions, and signed documentation.
• Review and revise supplement labels so they comply with all FDA requirements, including nutrition facts formatting, allergen statements, and permissible structure/function claims. Provide red-line comments and final print-ready files.
• File all prior-notice submissions through ACE, deliver confirmation numbers, and coordinate with the customs broker to secure clearance before the shipment lands.
Engagement rhythm
Shipments will average 1 to 2 per quarter at present. I need label comments turned around within 48 hours of request and prior-notice filings completed at least 10 business days before ETA. Once we establish a smooth process, I intend to move to a standing retainer.
Deliverables for each shipment
1. Signed FSVP record set (Just review of what we have already drafted) (PDF)
2. Final compliant label artwork (AI/PDF) plus change log
3. CBP/FDA prior-notice confirmation numbers and entry packet
If you can begin this month and meet those timelines, send me a short note outlining your toolset and response times, and we’ll set up a quick call to review the current supplier files.
Your background must include hands-on experience with FDA Supplements Label Review, FSVP Monitoring, and Customs Prenotification. Please reference specific brands, SKUs, or importers you have supported so I can see the depth of your expertise. Familiarity with 21 CFR 101, DSHEA, Prop 65, the FDA PREDICT system, and the ACE portal is expected; PCQI or FSVP QII credentials would be a welcome bonus.
Scope of work
• Monitor and maintain complete, auditable FSVP records for each foreign supplier—hazard analyses, verification activities, corrective actions, and signed documentation.
• Review and revise supplement labels so they comply with all FDA requirements, including nutrition facts formatting, allergen statements, and permissible structure/function claims. Provide red-line comments and final print-ready files.
• File all prior-notice submissions through ACE, deliver confirmation numbers, and coordinate with the customs broker to secure clearance before the shipment lands.
Engagement rhythm
Shipments will average 1 to 2 per quarter at present. I need label comments turned around within 48 hours of request and prior-notice filings completed at least 10 business days before ETA. Once we establish a smooth process, I intend to move to a standing retainer.
Deliverables for each shipment
1. Signed FSVP record set (Just review of what we have already drafted) (PDF)
2. Final compliant label artwork (AI/PDF) plus change log
3. CBP/FDA prior-notice confirmation numbers and entry packet
If you can begin this month and meet those timelines, send me a short note outlining your toolset and response times, and we’ll set up a quick call to review the current supplier files.
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