Violation Code: 186
FDA Violation
Charge Code: INSANITARY
Violation Details
- Violation Code (ASC ID)
- 186
- Charge Code
- INSANITARY
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
- Legal Section
- 501(a)(2)(A), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Strauss Health Ltd | M/P Misgav, ISRAEL | 53 |
| 2 | Strauss Salads Ltd | Carmind, ISRAEL | 16 |
| 3 | Incredible Products, SA de CV | Guadalajara, MEXICO | 9 |
| 4 | Aurobindo Pharma Limited | Mahabubnagar, INDIA | 7 |
| 5 | Becton Dickinson & Company | Franklin Lakes, UNITED STA | 5 |
| 6 | Cesar Gaona Jaramillo | Guayaquil, ECUADOR | 5 |
| 7 | Medline Industries, LP | Northfield, UNITED STA | 4 |
| 8 | Biome Restoration | Lancaster, UNITED KIN | 4 |
| 9 | Ahmed M.S. AL DIRANI AND BROS FACTORY | Zahle, LEBANON | 4 |
| 10 | Hangzhou Facecare Cosmetics Co., Ltd. | Hangzhou, CHINA | 4 |
| 11 | Emd Serono Canada | Edmonton, CANADA | 3 |
| 12 | Medical Action Industries Inc | Brentwood, UNITED STA | 3 |
| 13 | DULCERIA AURORA | Cofradia, HONDURAS | 3 |
| 14 | Albahealth LLC | Rockwood, UNITED STA | 3 |
| 15 | Teleflex Medical de Mexico, S. de R.L. de C.V. | Nuevo Laredo, MEXICO | 3 |
| 16 | Desert'S Farm In Sonora | Navojoa, MEXICO | 3 |
| 17 | Vetter Pharma Fertigung GmbH & Co. KG | Ravensburg, GERMANY | 3 |
| 18 | Tianjin Tianyao Pharmaceuticals Co., Ltd. | Tianjin Economic-Technological, CHINA | 3 |
| 19 | Australian Bright Seafoods | Port Lincoln, AUSTRALIA | 3 |
| 20 | A.R Medicom Inc (Shanghai) Ltd. | Shanghai, CHINA | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/28/2025 | GOURMAY, GOURAMI 16AVD52 | |
| 10/28/2025 | CROAKER 16AVT13 | |
| 8/21/2025 | CONDOM 85HIS | |
| 10/30/2024 | CONDOM 85HIS | Cupid Ltd.INDIA |
| 3/14/2024 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 3/14/2024 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 3/14/2024 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 1/17/2024 | GLOVE, PATIENT EXAMINATION, LATEX 80LYY | Pt. Shamrock Manufacturing Corp.INDONESIA |
| 9/7/2023 | SUPPRESSANT N.E.C. 66FDY99 | |
| 2/21/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBT99 | |
| 7/18/2022 | PLUM, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED 21JGT14 | DULCERIA AURORAHONDURAS |
| 7/18/2022 | MIXED FRUIT, JUICES OR CONCENTRATES N.E.C., 21DGT99 | LacthosaHONDURAS |
| 7/18/2022 | COFFEE, GROUND 31AGT02 | CAFE EL INDIOHONDURAS |
| 7/18/2022 | CASHEW, SHELLED 23BGT03 | DULCERIA AURORAHONDURAS |
| 7/18/2022 | BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) 24AGT99 | CORPORACION DINANT S.A. DE CVHONDURAS |
Related Violations
Other violations under the same legal section: 501(a)(2)(A), 801(a)(3); ADULTERATION
| Code | Charge Code | Cases |
|---|---|---|
| 78 | STERILITY | 510 |
Frequently Asked Questions
What is FDA violation code 186?
186 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.". This violation is based on 501(a)(2)(A), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 186?
According to FDA Import Refusal data, there have been 282 import refusals issued for violation code 186, affecting 151 unique firms.
When was the most recent refusal for violation 186?
The most recent import refusal for violation 186 was on October 28, 2025.
What products are commonly refused for violation 186?
Products commonly refused under violation 186 include: GOURMAY, GOURAMI, CROAKER, CONDOM, SHAMPOOS (HAIR PREPARATIONS, NON-COLORING). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 186?
Violation code 186 is based on 501(a)(2)(A), 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.