Violation Code: 83
FDA Violation
Charge Code: NO PROCESS
Violation Details
- Violation Code (ASC ID)
- 83
- Charge Code
- NO PROCESS
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
- Legal Section
- 402(a)(4), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | H J Heinz Co Ltd | Hayes, UNITED KIN | 187 |
| 2 | Derval | Derval, FRANCE | 140 |
| 3 | PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk | Bandung, INDONESIA | 106 |
| 4 | Premier Foods Limited (Long Sutton Site) | Spalding, UNITED KIN | 99 |
| 5 | Al-Durra Food Products Co. | Erbeen - Damascus, SYRIA | 91 |
| 6 | Green Market (Qingdao) Food Products Co Ltd | Qingdao, CHINA | 91 |
| 7 | Kimlan Foods Co., Ltd. | Taoyuan City, TAIWAN | 90 |
| 8 | MACKAYS LIMITED | Arbroath, UNITED KIN | 89 |
| 9 | Maeil Dairies Co., Ltd- GWANGJU PLANT | Gwangsan-Ku, SOUTH KORE | 83 |
| 10 | Haldiram Exports (Pvt) Limited | New Delhi, INDIA | 82 |
| 11 | Lanka Canneries (Pvt) Ltd. | Atthanagalla, SRI LANKA | 82 |
| 12 | ADF Foods Limited | Nadiad, INDIA | 80 |
| 13 | NisaWay / Bibby Distribution | Scunthorpe, UNITED KIN | 78 |
| 14 | Agroindustrias Deandar de Delicias S.A. de C.V. | Delicias, MEXICO | 66 |
| 15 | ALHELALI & ALMAWALDI CO. | Damascus, SYRIA | 56 |
| 16 | Baktat Gida San. Ve. Tic. Ltd. Sti. | Bursa, TURKEY | 54 |
| 17 | Shwe Hinthar Yeik Mon Co., Ltd | Yangon, MYANMAR | 54 |
| 18 | Turner & Price Limited | Hull, UNITED KIN | 50 |
| 19 | Elmac Foods | Haora, INDIA | 45 |
| 20 | MTR Foods Private Limited | Bangalore, INDIA | 45 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/29/2025 | TRUFFLE, FUNGI PRODUCTS, N.E.C. 25SYY02 | |
| 12/29/2025 | TRUFFLE, FUNGI PRODUCTS, N.E.C. 25SYY02 | |
| 12/17/2025 | CHILI SAUCE 37JCT03 | |
| 12/17/2025 | SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE) 33JGT99 | |
| 12/17/2025 | SAUCES, N.E.C. 37JHT99 | |
| 12/16/2025 | OLIVES (PIT FRUIT) 21GYT09 | |
| 12/16/2025 | FLUID MILK PRODUCTS, SKIM, 1%, 2%, WHOLE AND ALL FLAVORED AND MODIFIED (LACTOSE REDUCED, IE) GRADE A 09HFS08 | |
| 12/14/2025 | STEAK AND OTHER MEAT SAUCE 37JGI07 | Steiner, S.A. de C.V.EL SALVADO |
| 12/14/2025 | STEAK AND OTHER MEAT SAUCE 37JGI07 | Steiner, S.A. de C.V.EL SALVADO |
| 12/14/2025 | STEAK AND OTHER MEAT SAUCE 37JGI07 | Steiner, S.A. de C.V.EL SALVADO |
| 12/11/2025 | GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY 33MCE03 | Jellico Food Co, Ltd.TAIWAN |
| 12/11/2025 | GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY 33MCE03 | Jellico Food Co, Ltd.TAIWAN |
| 12/11/2025 | TZAHP CHOY (CHINESE CANNED SWEET PICKLES MADE FROM MIXED VEGETABLES) (MIXED VEGETABLES) 25ECT14 | |
| 12/9/2025 | CHILI SAUCE 37JHT03 | PT. JAVA HARVEST TRADINGINDONESIA |
| 12/8/2025 | CARBONATED SOFT DRINK, N.E.C. 29BEH99 |
Related Violations
Other violations under the same legal section: 402(a)(4), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 83?
83 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.". 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 83?
According to FDA Import Refusal data, there have been 21145 import refusals issued for violation code 83, affecting 6030 unique firms.
When was the most recent refusal for violation 83?
The most recent import refusal for violation 83 was on December 29, 2025.
What products are commonly refused for violation 83?
Products commonly refused under violation 83 include: TRUFFLE, FUNGI PRODUCTS, N.E.C., CHILI SAUCE, SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE), SAUCES, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 83?
Violation code 83 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.