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PPriority · FDA Food Code 3-201.11 · Immediate correction or discard (Priority)

How to fix: Food from Unapproved or Unregulated Source

Food on the premises was obtained from a source not inspected or regulated by a government food safety authority.

What this violation means

FDA Food Code 3-201.11 requires that all food used in a food service operation come from sources that are inspected and regulated by a government food safety authority. This means purchasing food from licensed distributors, USDA-inspected processors, licensed farms, or approved retail establishments. Homemade food, food from unapproved home kitchens, uninspected slaughter, wild-caught fish from unlicensed sources, or food purchased from unlicensed vendors all violate this requirement. Inspectors check invoices, delivery records, and labels to verify source.

Step-by-step: how to fix this before re-inspection

1Remove and discard any food that cannot be traced to a licensed, inspected source
2Gather invoices and delivery receipts for all food currently on the premises and keep them available for inspection
3Purchase all food exclusively from licensed distributors or retail establishments with verifiable inspection records
4Train purchasing staff and managers on approved source requirements
5Keep at least 90 days of purchase invoices on file and organized by date

What the inspector rechecks at re-inspection

WHAT THE INSPECTOR CHECKS

Inspectors do not just look at the surface. For this violation, expect them to verify:

Reviews invoices and purchase records for all food on premises
Checks food labels for USDA, FDA, or state inspection marks
Asks about the source of any unlabeled or home-packaged food
Looks for commercially produced food in unmarked containers
Verifies shellfish tags are present and match invoice quantities

How to prevent this violation from recurring

Maintain an approved vendor list and require manager sign-off for any new food supplier
Never accept donations of home-cooked or home-processed food for service
Include invoice verification as part of your receiving checklist

Related violations to check

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This document is for informational purposes only. It is not legal advice and does not guarantee a passing re-inspection score. Always verify requirements with your local health department. Fix steps are based on FDA Food Code 3-201.11; individual jurisdictions may have additional requirements.

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