Mizkan Euro Ltd. (Middleton)

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

Refusal charges, in plain English

• INADPRCCTL3 refused lines

  Inadequate process controls

  The product appeared to have been prepared, packed, or held under insanitary conditions because of inadequate process controls, whereby it may have become contaminated or injurious to health.

• NEEDS ACID3 refused lines

  NEEDS ACID

• NO PROCESS2 refused lines

  No scheduled process filed

  The manufacturer appeared not to have filed a scheduled process with FDA, which 21 CFR Part 108 requires for low-acid canned and acidified foods, so the product is treated as made under insanitary conditions.

• NEEDS FCE1 refused line

  Processor not registered for canned or acidified foods

  The manufacturer appeared not to be registered with FDA as a low-acid canned food or acidified food processor, as 21 CFR 108.25 and 108.35 require.

• 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 Mizkan Euro Ltd. (Middleton)

Is Mizkan Euro Ltd. (Middleton) on an FDA import alert?

Yes. As of October 26, 2026, Mizkan Euro Ltd. (Middleton) is on the red list of FDA Import Alert 99-38, “Low-acid canned/acidified foods: inadequate process control”, for all pickled sweet onion products; FDA published the listing on April 6, 2026.

Has FDA refused shipments from Mizkan Euro Ltd. (Middleton)?

Yes. FDA refused 4 shipment lines from Mizkan Euro Ltd. (Middleton) between November 28, 2018 and August 12, 2026. The most recent, on August 12, 2026, was onion bulb (yellow, white, red, etc.) (root & tuber vegetable), charged as INADPRCCTL (inadequate process controls).

Why did FDA refuse Mizkan Euro Ltd. (Middleton)'s shipments?

The most frequent charges are INADPRCCTL (inadequate process controls, 3 lines) and NEEDS ACID (needs acid, 3 lines).

When was Mizkan Euro Ltd. (Middleton) last inspected by FDA?

FDA's most recent inspection of Mizkan Euro Ltd. (Middleton) with a final classification is dated October 10, 2025 and was classified OAI (Official Action Indicated).

What is Mizkan Euro Ltd. (Middleton)'s FEI number?

Mizkan Euro Ltd. (Middleton)'s FDA Establishment Identifier (FEI) is 3004266834.

Can shipments from Mizkan Euro Ltd. (Middleton) still enter the U.S.?

Shipments of all pickled sweet onion products from Mizkan Euro Ltd. (Middleton) can be detained without physical examination under Import Alert 99-38; 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).