Violation Code: 3380
FDA Violation
Charge Code: EXPIRED
Violation Details
- Violation Code (ASC ID)
- 3380
- Charge Code
- EXPIRED
- Description
- the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.
- Legal Section
- 501(c); 801(a)(3) Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Carnival Cruise Lines | Freeport City, BAHAMAS | 115 |
| 2 | Bellegrove Medical Supply, Inc. | Redmond, UNITED STA | 5 |
| 3 | Zhejiang Bangli Medical Products Co., Ltd | Yongkang, CHINA | 5 |
| 4 | Holland America Line - | Seattle, UNITED STA | 3 |
| 5 | ASO Americas, S. de RL de C.V. | Juarez, MEXICO | 3 |
| 6 | Medecins Sans Frontieres | Cite Soleil, HAITI | 2 |
| 7 | Corporativo Serysi, S. De R.L. De C.V. | Zapopan, MEXICO | 2 |
| 8 | GLOBAL FARMS S.A. | Vista Hermosa, GUATEMALA | 2 |
| 9 | Lipoid GmbH | Ludwigshafen Am Rhein, GERMANY | 1 |
| 10 | Philips North America LLC | Bothell, UNITED STA | 1 |
| 11 | Biologische Heilmittel Heel Gmbh | Baden-Baden, GERMANY | 1 |
| 12 | International Custom Pak Inc. | Beamsville, CANADA | 1 |
| 13 | Wyeth Animal Health | Guelph, CANADA | 1 |
| 14 | Constant Irwindale, Inc. | Irwindale, UNITED STA | 1 |
| 15 | ForeverGreen International, LLC | Lindon, UNITED STA | 1 |
| 16 | Orion Group | Wolfville, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 4/24/2023 | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) 74MKJ | Philips North America LLCUNITED STA |
| 11/8/2021 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBY99 | GLOBAL FARMS S.A.GUATEMALA |
| 11/8/2021 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBY99 | GLOBAL FARMS S.A.GUATEMALA |
| 11/2/2017 | ANALGESIC, N.E.C. 60LBL99 | |
| 11/2/2017 | ANALGESIC, N.E.C. 60LBL99 | |
| 6/3/2014 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 6/3/2014 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 6/3/2014 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 3/26/2014 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | ForeverGreen International, LLCUNITED STA |
| 8/26/2013 | ABRASIVE N.E.C. 60AAA99 | |
| 8/26/2013 | TETRACYCLINE N.E.C. 56EAA99 | |
| 11/9/2012 | DISINFECTANT N.E.C. 64AAK99 | |
| 9/26/2012 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | Holland America Line -UNITED STA |
| 8/10/2012 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | Holland America Line -UNITED STA |
| 5/25/2012 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | Bellegrove Medical Supply, Inc.UNITED STA |
Related Violations
Other violations under the same legal section: 501(c); 801(a)(3) Adulteration
Frequently Asked Questions
What is FDA violation code 3380?
3380 is an FDA violation code that indicates: "the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.". This violation is based on 501(c); 801(a)(3) Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3380?
According to FDA Import Refusal data, there have been 145 import refusals issued for violation code 3380, affecting 16 unique firms.
When was the most recent refusal for violation 3380?
The most recent import refusal for violation 3380 was on April 24, 2023.
What products are commonly refused for violation 3380?
Products commonly refused under violation 3380 include: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE), MISCELLANEOUS PATENT MEDICINES, ETC., ANALGESIC, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3380?
Violation code 3380 is based on 501(c); 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.