Dietary Supplement Ingredient — Mistaking §1.511 for §1.502
Applying Standard Food FSVP to a Supplement — a Structural Error
Situation
A company importing a Korean dietary-supplement ingredient (red ginseng extract) followed a generic FSVP guide and diligently documented its hazard analysis, supplier evaluation, and verification activities in English.
Problem
During an FDA FSVP inspection, the company was cited for having no review record of whether the supplier complies with 21 CFR Part 111 (CGMP). The generic food-FSVP guide the file was built on simply never included the CGMP-compliance check that the supplement-specific provision (§1.511) requires.
Timeline
- FDA inspection requested
- After review — cited for missing a CGMP (Part 111) compliance-verification record under §1.511
- Remediation period — supplier's CGMP audit report requested, existing FSVP file updated
- After submission — conditional approval, updated FSVP standard applied starting with the next shipment
Losses
Time spent on remediationDelay from re-requesting the supplier's CGMP documents
📌 Supplement FSVP = §1.511 + confirming CGMP Part 111 compliance. Don't reuse a generic food FSVP template as-is.