Has FDA refused shipments from Milchwerke "Mittelelbe" GmbH?

Yes. FDA refused 3 shipment lines from Milchwerke "Mittelelbe" GmbH between December 12, 2017 and August 19, 2026. The most recent, on August 19, 2026, was milk base infant formula product (0-12 months), powder formula, charged as INSANITARY (prepared, packed or held under insanitary conditions).

Why did FDA refuse Milchwerke "Mittelelbe" GmbH's shipments?

The most frequent charges are INSANITARY (prepared, packed or held under insanitary conditions, 2 lines) and NUTRIT LBL (nutrition information missing from label, 1 line).

When was Milchwerke "Mittelelbe" GmbH last inspected by FDA?

FDA's most recent inspection of Milchwerke "Mittelelbe" GmbH with a final classification is dated May 8, 2026 and was classified OAI (Official Action Indicated).

What is Milchwerke "Mittelelbe" GmbH's FEI number?

Milchwerke "Mittelelbe" GmbH's FDA Establishment Identifier (FEI) is 3004662202.

Can shipments from Milchwerke "Mittelelbe" GmbH still enter the U.S.?

Shipments of all powdered infant formula from Milchwerke "Mittelelbe" GmbH can be detained without physical examination under Import Alert 99-43; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

Milchwerke "Mittelelbe" GmbH

FDA import alert and refusal historyStendal, GermanyFEI 3004662202

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As of October 26, 2026, Milchwerke "Mittelelbe" GmbH (Stendal, Germany) is on the red list of FDA Import Alert 99-43 (Ready-to-eat foods: insanitary conditions) for all powdered infant formula, published by FDA on October 1, 2026, is also listed on Import Alert 40-05 (red list), and has 3 FDA import refusals recorded since October 2016.

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

Current status

Import alerts: IA 99-43 · red list IA 40-05 · red list
Last import refusal: Aug 19, 2026Milk base infant formula product (0-12 months), powder formula · INSANITARY
Last warning letter: None found
Last inspection: May 8, 2026Classified OAI (Official Action Indicated)

Every FDA record for Milchwerke "Mittelelbe" GmbH

7 records, newest first. Each line links to the FDA page it came from.

2026

Oct 1, 2026Import alert listing
Listed on Import Alert 99-43red listAll Powdered Infant Formula
Source
Aug 19, 2026Import refusal
Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaINSANITARYEntry 551-2760150-5Show 2 linesHide lines
- Refused, Milk base infant formula product (0-12 months), powder formulaINSANITARYEntry 551-2760150-5Source
- Refused, Milk base infant formula product (0-12 months), powder formulaINSANITARYEntry 551-2760150-5Source
Source
Jun 26, 2026Import alert listing
Listed on Import Alert 40-05red listPowdered Infant Formula
Source
May 8, 2026Inspection
Inspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards
Source

2017

Dec 12, 2017Import refusal
Refused, Milk, flavored, low fatNUTRIT LBLEntry BGZ-0051412-9
Source
Jan 19, 2017Inspection
Inspection classified NAI (No Action Indicated)Foodborne Biological Hazards
Source

Refusal charges, in plain English

INSANITARY2 refused lines
Prepared, packed or held under insanitary conditions
The product appeared to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health.
NUTRIT LBL1 refused line
Nutrition information missing from label
The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

Questions about Milchwerke "Mittelelbe" GmbH

Is Milchwerke "Mittelelbe" GmbH on an FDA import alert?: Yes. As of October 26, 2026, Milchwerke "Mittelelbe" GmbH is on the red list of FDA Import Alert 99-43, “Ready-to-eat foods: insanitary conditions”, for all powdered infant formula; FDA published the listing on October 1, 2026.
Has FDA refused shipments from Milchwerke "Mittelelbe" GmbH?: Yes. FDA refused 3 shipment lines from Milchwerke "Mittelelbe" GmbH between December 12, 2017 and August 19, 2026. The most recent, on August 19, 2026, was milk base infant formula product (0-12 months), powder formula, charged as INSANITARY (prepared, packed or held under insanitary conditions).
Why did FDA refuse Milchwerke "Mittelelbe" GmbH's shipments?: The most frequent charges are INSANITARY (prepared, packed or held under insanitary conditions, 2 lines) and NUTRIT LBL (nutrition information missing from label, 1 line).
When was Milchwerke "Mittelelbe" GmbH last inspected by FDA?: FDA's most recent inspection of Milchwerke "Mittelelbe" GmbH with a final classification is dated May 8, 2026 and was classified OAI (Official Action Indicated).
What is Milchwerke "Mittelelbe" GmbH's FEI number?: Milchwerke "Mittelelbe" GmbH's FDA Establishment Identifier (FEI) is 3004662202.
Can shipments from Milchwerke "Mittelelbe" GmbH still enter the U.S.?: Shipments of all powdered infant formula from Milchwerke "Mittelelbe" GmbH can be detained without physical examination under Import Alert 99-43; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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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.