MarketUnited StatesFSVP Supplier Qualification Pack
Structure foreign supplier verification records for FDA inspections and identify expired annual audits or missing hazard evaluations before PCQI review.
Not published yet. This capability is on the roadmap and nobody has claimed it yet. What you see below is a proposal, not something you can use today. Claim it as a publisher.
Which market this reads
What this check reads: United States. No other market is covered.
Grounded in FDA FSVP rules under 21 CFR Part 1 Subpart L. Identifies foreign supplier verification record gaps for PCQI review. Refuses legal compliance determinations.
What it does
Assembles foreign supplier verification file records and identifies documentation gaps under FDA FSVP 21 CFR Part 1 Subpart L without issuing legal determinations.
Ask it like this
youWhat mandatory documents are required for foreign supplier verification activities under FSVP 21 CFR 1.506?
You never name it yourself. Your assistant picks the right tool: us_fsvp_supplier_qualification_pack__lookup_fsvp_verification_rules
What you give it
| What to give | Kind of value | Needed? | Notes |
|---|---|---|---|
| fsvp_component | string | yes | lookup: FSVP file component (Hazard Analysis, Supplier Evaluation, Verification Activity, Re-evaluation) |
| foreign_supplier_name | string | yes | audit: Name of foreign supplier facility |
| verification_records | array | yes | audit: array of uploaded file objects with document_type and document_date |
What you get back
| What comes back | Kind of value | Notes |
|---|---|---|
| mandatory_documents | string | lookup: required documents under 21 CFR Part 1 Subpart L |
| cfr_reference | string | lookup: specific 21 CFR citation |
| completeness_score | number | audit: percentage completeness score (0-100) |
| missing_documents | array | audit: array of missing or expired required documents |
| disclaimer | string | states formatting and gap checklist results, refusing legal compliance verdicts |
Sources
- Title 21 CFR Part 1 Subpart L (21 CFR 1.500 through 1.514)
- FDA Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Who wrote this
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How uncertainty is handled
This check reports a confidence score with every answer. Below 80 out of 100 nothing is guessed: the uncertain items go to a review queue and the answer comes back marked "needs review".
Read how quality levels work