Violation Code: 238
FDA Violation
Charge Code: UNSAFE ADD
Violation Details
- Violation Code (ASC ID)
- 238
- Charge Code
- UNSAFE ADD
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
- Legal Section
- 402(a)(2)(C)(i), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Nutri-Asia, Incorporated dba UFC Philippines | Laguna, PHILIPPINE | 416 |
| 2 | Nutri-Asia | Bulacan, PHILIPPINE | 164 |
| 3 | Mars Petcare | Victorville, UNITED STA | 123 |
| 4 | Nestle India Limited | Bicholim, INDIA | 105 |
| 5 | Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...) | Puebla, MEXICO | 72 |
| 6 | Yelin Hoitat Quick Frozen Seafood Co., Ltd. | Yangjiang, CHINA | 70 |
| 7 | DIVINE ATMOS PRIVATE LIMITED | Coimbatore, INDIA | 69 |
| 8 | chilemex s.a. de c.v. | Villahermosa, MEXICO | 61 |
| 9 | Mythos Native Art | Quito, ECUADOR | 58 |
| 10 | Alltech do Brasil | Sao Pedro Do Ivai, BRAZIL | 55 |
| 11 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 51 |
| 12 | Cadbury Trebor Bassett | Birmingham, UNITED KIN | 47 |
| 13 | Shantou Olive Pharmaceutical Co.,Ltd | Shantou, CHINA | 46 |
| 14 | SGR (777) FOODS PRIVATE LIMITED | Gummidipoondi, INDIA | 43 |
| 15 | Nutri-Asia, Inc | Tagiug City, PHILIPPINE | 43 |
| 16 | DIVINE ATMOS PRIVATE LIMITED | Sundapalayam, INDIA | 42 |
| 17 | Gregoria Ramirez Hernandez | Guadalajara, MEXICO | 38 |
| 18 | Aleshin E.O | Abakan, RUSSIA | 34 |
| 19 | Marie Daage Diffusion | Paris, FRANCE | 31 |
| 20 | VAHDAM TEAS PVT LT | Noida, INDIA | 30 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | APPLE, CORE FRUIT JUICES OR CONCENTRATES 20SGY01 | |
| 12/16/2025 | SHRIMP & PRAWNS 16JGD05 | |
| 12/14/2025 | BETEL NUT, IN SHELL 23AYY14 | MUANG MAI MARKETTHAILAND |
| 12/14/2025 | BETEL NUT (HERBAL AND BOTANICALS, NOT TEAS II) 54KBY11 | ALL GENERATION CO., LTD.THAILAND |
| 12/14/2025 | BETEL NUT, IN SHELL 23AGT14 | |
| 12/11/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCA99 | OMEGA NUTRITIONMEXICO |
| 12/10/2025 | SHRIMP & PRAWNS 16JYH05 | BEH CHIN KOK TRADINGMALAYSIA |
| 12/8/2025 | MUSTARD OIL SEED STOCK 26BYY11 | ETS FALLOTFRANCE |
| 12/1/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BGT99 | D.M. Mexicana SA de CVMEXICO |
| 12/1/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BGT99 | D.M. Mexicana SA de CVMEXICO |
| 12/1/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BGT99 | D.M. Mexicana SA de CVMEXICO |
| 12/1/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BGT99 | D.M. Mexicana SA de CVMEXICO |
| 12/1/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BGT99 | D.M. Mexicana SA de CVMEXICO |
| 12/1/2025 | ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C. 54GCL99 | Pharmtech KoreaSOUTH KORE |
| 12/1/2025 | HONEY 36CYT04 |
Related Violations
Other violations under the same legal section: 402(a)(2)(C)(i), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 238?
238 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 bear or contain an unsafe food additive within the meaning of section 409.". This violation is based on 402(a)(2)(C)(i), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 238?
According to FDA Import Refusal data, there have been 6893 import refusals issued for violation code 238, affecting 2125 unique firms.
When was the most recent refusal for violation 238?
The most recent import refusal for violation 238 was on December 31, 2025.
What products are commonly refused for violation 238?
Products commonly refused under violation 238 include: APPLE, CORE FRUIT JUICES OR CONCENTRATES, SHRIMP & PRAWNS, BETEL NUT, IN SHELL, BETEL NUT (HERBAL AND BOTANICALS, NOT TEAS II). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 238?
Violation code 238 is based on 402(a)(2)(C)(i), 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.