FAQ
Questions around FDA readiness, inspections, and botanical compliance.
Guidance for botanical manufacturers entering or operating in the US market.
Topics
01
Getting Started
02
FSMA & FSVP
03
Registration & us Agent
04
Audits & Inspection
01
Getting Started
We've never engaged with FDA before. Where do we begin?
We typically start with a facility diagnostic — a structured gap analysis against the regulations applicable to your product class (FSMA Subpart C/G for foods, 21 CFR 111 for dietary supplements). The output is a prioritised compliance roadmap with timelines and resource estimates.
How long does it take to become FDA compliant?
Most international botanical manufacturers reach a defensible compliance posture within 4 to 9 months, depending on facility complexity, existing QMS maturity, and supplier network size. We design phased rollouts so you can begin shipping while later stages mature.
Do you work with companies of all sizes?
Yes. We support emerging exporters preparing their first US shipment, mid-market manufacturers scaling distribution, and established suppliers responding to FDA observations or Warning Letters.
02
FSMA & FSVP
What's the difference between FSMA and FSVP?
FSMA is the broader Food Safety Modernization Act. FSVP — Foreign Supplier Verification Program — is one specific FSMA rule that places obligations on US importers to verify their foreign suppliers. If you sell into the US through an importer, both regimes affect you.
Does FSMA apply to dietary supplement ingredients?
Generally, dietary supplements are regulated under 21 CFR 111 (cGMP for dietary supplements) rather than FSMA preventive controls. However, ingredients that may be used in conventional foods can fall under FSMA. We help clarify which framework governs your specific products.
03
Registration &us Agent
Do we need a US Agent if we're a foreign facility?
We typically start with a facility diagnostic — a structured gap analysis against the regulations applicable to your product class (FSMA Subpart C/G for foods, 21 CFR 111 for dietary supplements). The output is a prioritised compliance roadmap with timelines and resource estimates.
How often do we need to renew registration?
Most international botanical manufacturers reach a defensible compliance posture within 4 to 9 months, depending on facility complexity, existing QMS maturity, and supplier network size. We design phased rollouts so you can begin shipping while later stages mature.
04
Audits & Inspection
Will FDA actually inspect a foreign facility?
Yes. FDA conducts foreign facility inspections, particularly for high-priority categories. Frequency has increased in recent years. Even without an on-site inspection, FDA may issue Import Alerts or hold shipments based on records reviews.
What happens if we receive a Form 483 or Warning Letter?
We provide rapid-response remediation: root-cause analysis, CAPA development, written response drafting, and ongoing monitoring. Time matters — FDA expects substantive responses within 15 working days for Warning Letters.