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 |
|---|---|---|
| 1/22/2026 | SAUCES, N.E.C. 37JCI99 | SACLA CDAITALY |
| 1/22/2026 | ARTICHOKE, WITH SAUCE 24VCN01 | SACLA CDAITALY |
| 1/22/2026 | BASIL SAUCE (WITH OTHER INGREDIENTS) 37JCI25 | SACLA CDAITALY |
| 1/22/2026 | CONDIMENTS, N.E.C. 27YCH99 | |
| 1/21/2026 | OLIVES (PIT FRUIT) 21GYT09 | |
| 1/16/2026 | YANANG LEAVES (LEAF & STEM VEGETABLE) 24TEE41 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | BAMBOO SHOOTS (LEAF & STEM VEGETABLE) 24TEE03 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | BANANA (SUBTROPICAL AND TROPICAL FRUIT) 21SEE02 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | PAPAYA (PAPAW) (SUBTROPICAL AND TROPICAL FRUIT PUREES) 21REE06 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | BAMBOO SHOOTS (LEAF & STEM VEGETABLE) 24TEE03 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | RELISH, VEGETABLE BASED RELISH 27YGT11 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | RELISH, VEGETABLE BASED RELISH 27YCT11 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | CITRUS FRUIT, N.E.C. 20GEE99 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | TURMERIC, WHOLE (SPICE) 28AEE49 | MAE KHEM CO LTDTHAILAND |
| 1/14/2026 | MAYONNAISE 27AGB02 |
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 21174 import refusals issued for violation code 83, affecting 6040 unique firms.
When was the most recent refusal for violation 83?
The most recent import refusal for violation 83 was on January 22, 2026.
What products are commonly refused for violation 83?
Products commonly refused under violation 83 include: SAUCES, N.E.C., ARTICHOKE, WITH SAUCE, BASIL SAUCE (WITH OTHER INGREDIENTS), CONDIMENTS, N.E.C., OLIVES (PIT FRUIT). 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.