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Violation Code: 3898

FDA Violation

Charge Code: INADPRCCTL

273
Total Refusals
31
Affected Firms
12/22/2025
Latest Case
12/4/2020
First Case

Violation Details

Violation Code (ASC ID)
3898
Charge Code
INADPRCCTL
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate process controls.
Legal Section
402(a)(4), 801(a)(3); ADULTERATION

Most Affected Firms

Recent Import Refusals

DateProductFirm
12/22/2025
ONION BULB (YELLOW, WHITE, RED, ETC.), JUICE OR DRINK
25MGE25
12/16/2025
OLIVES (PIT FRUIT)
21GYT09
12/12/2025
BAMBOO SHOOTS, DRIED OR PASTE
24UGY03
12/12/2025
BAMBOO SHOOTS, DRIED OR PASTE
24UGY03
11/24/2025
COFFEE DRINK
31GGT01
11/19/2025
GRASS JELLY DRINK BEVERAGE BASE
30YGT01
11/19/2025
GRASS JELLY DRINK BEVERAGE BASE
30YGT01
11/19/2025
GRASS JELLY DRINK BEVERAGE BASE
30YGT01
11/17/2025
TEA, GREEN
31KGH02
11/17/2025
COFFEE DRINK
31GGT01
11/17/2025
GRASS JELLY DRINK BEVERAGE BASE
30YGT01
11/17/2025
GRASS JELLY DRINK BEVERAGE BASE
30YGT01
11/17/2025
GRASS JELLY DRINK BEVERAGE BASE
30YGT01
11/14/2025
OLIVES, BLACK, (PIT FRUIT)
21GEE10
11/13/2025
OLIVES, BLACK, (PIT FRUIT)
21GEE10

Related Violations

Other violations under the same legal section: 402(a)(4), 801(a)(3); ADULTERATION

CodeCharge CodeCases
83NO PROCESS21145
62NEEDS FCE13735
306INSANITARY4036
181UNDER PRC814
48NEEDS ACID451
3161NONRSP-PRC74
152SOAKED/WET73
3240NOCONTCODE53

Frequently Asked Questions

What is FDA violation code 3898?

3898 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate process controls.". This violation is based on 402(a)(4), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3898?

According to FDA Import Refusal data, there have been 273 import refusals issued for violation code 3898, affecting 31 unique firms.

When was the most recent refusal for violation 3898?

The most recent import refusal for violation 3898 was on December 22, 2025.

What products are commonly refused for violation 3898?

Products commonly refused under violation 3898 include: ONION BULB (YELLOW, WHITE, RED, ETC.), JUICE OR DRINK, OLIVES (PIT FRUIT), BAMBOO SHOOTS, DRIED OR PASTE, COFFEE DRINK. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3898?

Violation code 3898 is based on 402(a)(4), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.