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FDA Untitled Letters Issued 2011-2018

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Detected March 23rd, 2026
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Summary

The FDA has posted a collection of 83 untitled letters issued between 2011 and 2018 by its Center for Food Safety and Applied Nutrition (CFSAN). These letters address violations related to manufacturing controls or labeling that did not meet the threshold for a Warning Letter.

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What changed

This document serves as a repository for untitled letters issued by the FDA's Center for Food Safety and Applied Nutrition (CFSAN) between December 2011 and 2018. These letters address violations of a less severe nature than those warranting a Warning Letter, including issues with manufacturing controls, labeling, and cyber letters sent to internet websites. The collection includes specific instances related to seafood facilities, unapproved food additives, low-acid canned foods, and other food-related compliance issues.

While these untitled letters are non-binding, they indicate areas of FDA enforcement focus and potential compliance gaps for food manufacturers. Companies should review these historical letters to understand common violations and ensure their manufacturing processes and labeling practices align with FDA expectations to avoid more significant regulatory action. No immediate compliance actions are required based on this notice, but it serves as an informational resource for ongoing compliance efforts.

What to do next

  1. Review historical untitled letters for common violations related to manufacturing controls and labeling.
  2. Ensure current manufacturing processes and labeling practices align with FDA expectations.

Source document (simplified)

Under the FDA transparency initiative, FDA began posting untitled letters issued by Center for Food Safety and Applied Nutrition (CFSAN) in December 2011, this includes violations from manufacturing controls or labeling that do not meet the threshold of regulatory significance for a Warning Letter, or that are issued to Internet websites (cyber letters).

2018

2017

2016

2015

2014

2013

2012

2011

11/15/2018

  • Regulated Product(s)

    • Food & Beverages

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Source

Favicon for www.fda.gov
FDA Untitled Letters fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/issuance-untitled-letters
Pharma & Drug Safety
Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Instrument
Enforcement
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Food manufacturers
Industry sector
3114 Food & Beverage Manufacturing
Activity scope
Food Manufacturing Food Labeling
Threshold
Violations that do not meet the threshold of regulatory significance for a Warning Letter
Geographic scope
United States US

Taxonomy

Primary area
Food Safety
Operational domain
Compliance
Topics
Manufacturing Controls Labeling

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