Has FDA refused shipments from Bio-Gen Milchserum Marketing GmbH?

Yes. FDA refused 2 shipment lines from Bio-Gen Milchserum Marketing GmbH on November 3, 2025. The most recent, on November 3, 2025, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as SUPPL GMP (dietary supplement cgmp not met).

Why did FDA refuse Bio-Gen Milchserum Marketing GmbH's shipments?

The most frequent charge is SUPPL GMP (dietary supplement cgmp not met, 2 lines).

When was Bio-Gen Milchserum Marketing GmbH last inspected by FDA?

FDA's most recent inspection of Bio-Gen Milchserum Marketing GmbH with a final classification is dated November 14, 2024 and was classified OAI (Official Action Indicated).

What is Bio-Gen Milchserum Marketing GmbH's FEI number?

Bio-Gen Milchserum Marketing GmbH's FDA Establishment Identifier (FEI) is 3014586415.

Can shipments from Bio-Gen Milchserum Marketing GmbH still enter the U.S.?

Shipments of hair plus; q10 plus from Bio-Gen Milchserum Marketing GmbH can be detained without physical examination under Import Alert 54-14; 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).

Bio-Gen Milchserum Marketing GmbH

FDA import alert and refusal historyMontabaur, GermanyFEI 3014586415

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As of October 26, 2026, Bio-Gen Milchserum Marketing GmbH (Montabaur, Germany) is on the red list of FDA Import Alert 54-14 (Supplements from firms not meeting supplement GMP) for hair plus; q10 plus, published by FDA on April 15, 2025, and has 2 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 54-14 · red list
Last import refusal: Nov 3, 2025Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · SUPPL GMP
Last warning letter: None found
Last inspection: Nov 14, 2024Classified OAI (Official Action Indicated)

Every FDA record for Bio-Gen Milchserum Marketing GmbH

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

2025

Nov 3, 2025Import refusal
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry AVB-1117015-2Show 2 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry AVB-1117015-2Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry AVB-1117015-2Source
Source
Apr 15, 2025Import alert listing
Listed on Import Alert 54-14red listHair Plus; Q10 Plus
Source

2024

Nov 14, 2024Inspection
Inspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards
Source

Refusal charges, in plain English

SUPPL GMP2 refused lines
Dietary supplement CGMP not met
The product appeared to be a dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice (CGMP) regulations.

Questions about Bio-Gen Milchserum Marketing GmbH

Is Bio-Gen Milchserum Marketing GmbH on an FDA import alert?: Yes. As of October 26, 2026, Bio-Gen Milchserum Marketing GmbH is on the red list of FDA Import Alert 54-14, “Supplements from firms not meeting supplement GMP”, for hair plus; q10 plus; FDA published the listing on April 15, 2025.
Has FDA refused shipments from Bio-Gen Milchserum Marketing GmbH?: Yes. FDA refused 2 shipment lines from Bio-Gen Milchserum Marketing GmbH on November 3, 2025. The most recent, on November 3, 2025, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as SUPPL GMP (dietary supplement cgmp not met).
Why did FDA refuse Bio-Gen Milchserum Marketing GmbH's shipments?: The most frequent charge is SUPPL GMP (dietary supplement cgmp not met, 2 lines).
When was Bio-Gen Milchserum Marketing GmbH last inspected by FDA?: FDA's most recent inspection of Bio-Gen Milchserum Marketing GmbH with a final classification is dated November 14, 2024 and was classified OAI (Official Action Indicated).
What is Bio-Gen Milchserum Marketing GmbH's FEI number?: Bio-Gen Milchserum Marketing GmbH's FDA Establishment Identifier (FEI) is 3014586415.
Can shipments from Bio-Gen Milchserum Marketing GmbH still enter the U.S.?: Shipments of hair plus; q10 plus from Bio-Gen Milchserum Marketing GmbH can be detained without physical examination under Import Alert 54-14; 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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