What is Import Alert 12-13?

Import Alert 12-13, “Detention without physical examination of milk and milk products manufactured under insanitary conditions”, is an FDA import alert. FDA may detain milk and milk products from the firms on its red list without physical examination; FDA last published the alert on May 22, 2026.

Which firms are on Import Alert 12-13?

As of October 26, 2026, 1 firm is listed on Import Alert 12-13 in 1 country; the most listings are in Germany (1). The full table, grouped by country, is below on this page and every firm links to its record.

How do firms get off Import Alert 12-13?

A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 12-13; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 12-13?

The charge section of Import Alert 12-13 names INSANITARY (prepared, packed or held under insanitary conditions). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

Import Alert 12-13: Detention without physical examination of milk and milk products manufactured under insanitary conditions

FDA last published May 22, 2026FDA alert page

As of October 26, 2026, FDA Import Alert 12-13 (Milk products made under insanitary conditions) lists 1 firm on its red list in 1 country, covering milk and milk products; 0 firms were added and 0 removed in the last 90 days.

Data from FDA public records, last checked October 26, 2026. Request a correction

1
firms on the red list: 1
country: 0
added in the last 90 days: 0
removed in the last 90 days

What changed in the last 90 days

Additions use the date FDA published each listing. Removals are dated by the day SupplierRadar first saw the firm gone; the weekly and daily checks are described on the data sources page.

Removed from Import Alert 12-13

SupplierRadar has recorded no removals from Import Alert 12-13 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.

Added to Import Alert 12-13

No firm was added to Import Alert 12-13 in the last 90 days, as of October 26, 2026.

Firms on Import Alert 12-13, by country

1 listing in 1 country. Each name links to the firm's FDA record history; the date is the one FDA published on the alert.

Listings by country

Import alert listings by country
Country	Red list	Total
Germany	1	1

Germany (1)

FDA refusals from Germany

Firms in Germany on Import Alert 12-13
Firm	List	Products	Date published
Edelweiss Gmbh & Co., KGKempten (Allgau)	Red	Blue Brie Cheese	Sep 18, 2013

Refusal charges named on this alert

FDA's alert page names these charge codes. The counts are refusal lines FDA recorded under each charge since October 2016, for all firms, not only firms on this alert.

Charge codes named on Import Alert 12-13
Charge code	Meaning	Refusal lines since 2016
INSANITARY	Prepared, packed or held under insanitary conditions	898

What the alert covers and why FDA issued it

FDA's wording, with FDA's change markers removed.

Official title: Detention Without Physical Examination of Milk and Milk Products Manufactured under Insanitary Conditions
Product scope: Milk and Milk Products: milk, cream, cheese, and all other milk-based products. See Guidance for exclusions.
Last published: May 22, 2026

FDA conducts inspections of foreign processors of milk and milk products to ensure products being offered for import into the US are safe and are manufactured under sanitary conditions in conformance with the FD&C Act and under Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). For example, measures such as pasteurizing (or other alternatives to pasteurizing such as aging) that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, holding, and distribution to prevent food from being adulterated (21 CFR 117.80(c)(4)). FDA assesses processors' pasteurization systems, including whether they are being adequately implemented, whether milk…
FDA may pursue regulatory action(s) based on inspectional observations or other evidence (e.g., noncompliance with Current Good Manufacturing Practice or Preventive Control requirements) gathered during foreign inspections of milk and milk products manufacturers that demonstrate improper pasteurization, inadequate aging, or other insanitary conditions which may result in the contamination of milk and milk products.

FDA Import Alert 12-13, Reason for AlertRead it on FDA

Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.

Questions about Import Alert 12-13

What is Import Alert 12-13?: Import Alert 12-13, “Detention without physical examination of milk and milk products manufactured under insanitary conditions”, is an FDA import alert. FDA may detain milk and milk products from the firms on its red list without physical examination; FDA last published the alert on May 22, 2026.
Which firms are on Import Alert 12-13?: As of October 26, 2026, 1 firm is listed on Import Alert 12-13 in 1 country; the most listings are in Germany (1). The full table, grouped by country, is below on this page and every firm links to its record.
How do firms get off Import Alert 12-13?: A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 12-13; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 12-13?: The charge section of Import Alert 12-13 names INSANITARY (prepared, packed or held under insanitary conditions). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
Which firms were added to Import Alert 12-13 recently?: No firm was added to Import Alert 12-13 in the last 90 days, as of October 26, 2026.
Which firms were removed from Import Alert 12-13 recently?: SupplierRadar has recorded no removals from Import Alert 12-13 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.