Violation Code: 3724
FDA Violation
Charge Code: DEVGMPS
Violation Details
- Violation Code (ASC ID)
- 3724
- Charge Code
- DEVGMPS
- Description
- The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
- Legal Section
- 520(f); 801(a)(1)
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Jiangsu Caina Medical Co., Ltd | Wuxi, CHINA | 20 |
| 2 | Jiangsu Shenli Medical Production Co., Ltd. | Changzhou, CHINA | 11 |
| 3 | Zhejiang Longde Pharmaceutical Co., Ltd | Hangzhou, CHINA | 8 |
| 4 | Greiner Bio-One GmbH | Kremsmunster, AUSTRIA | 8 |
| 5 | Nuga Medical Co., Ltd. | Wonju, SOUTH KORE | 7 |
| 6 | Alber GmbH | Albstadt, GERMANY | 7 |
| 7 | NIPRO CORP. | Odate, JAPAN | 5 |
| 8 | Greiner Bio-One Hungary Kft | Mosonmagyarovar, HUNGARY | 5 |
| 9 | Nipro Medical Industries, Ltd. | Tatebayashi, JAPAN | 4 |
| 10 | DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY | Dongguan, CHINA | 3 |
| 11 | F.L. Medical S.R.L. | Padova, ITALY | 3 |
| 12 | Serag-Wiessner Gmbh | Naila, GERMANY | 3 |
| 13 | P.T. Nipro Indonesia Jaya | Karawang, INDONESIA | 3 |
| 14 | Syntex Healthcare Products Co., Ltd. | Industrial Zone, CHINA | 3 |
| 15 | Contec Medical Systems Co., Ltd. | Qinhuangdao, CHINA | 2 |
| 16 | Ciba Vision Corporation | Des Plaines, UNITED STA | 2 |
| 17 | Stanmore Implants Worldwide Ltd. | Borehamwood, UNITED KIN | 2 |
| 18 | Sopro Comeg Gmbh | Tuttlingen, GERMANY | 2 |
| 19 | E-Care Technology Corp. | Chubei City, TAIWAN | 2 |
| 20 | ARTEMA MEDICAL GRO | Lahore, PAKISTAN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/1/2025 | OXIMETER, INFRARED, SPORTING, AVIATION 74OCH | |
| 12/1/2025 | OXIMETER, INFRARED, SPORTING, AVIATION 74OCH | |
| 10/20/2025 | MICRO PIPETTE 75JRC | Greiner Bio-One GmbHAUSTRIA |
| 10/20/2025 | TOURNIQUET, NONPNEUMATIC 79GAX | |
| 10/20/2025 | DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC 83LIB | Greiner Bio-One Hungary KftHUNGARY |
| 10/20/2025 | MICRO PIPETTE 75JRC | Greiner Bio-One GmbHAUSTRIA |
| 10/20/2025 | NEEDLE, HYPODERMIC, SINGLE LUMEN 80FMI | |
| 10/20/2025 | DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC 83LIB | Greiner Bio-One Hungary KftHUNGARY |
| 10/20/2025 | NEEDLE, HYPODERMIC, SINGLE LUMEN 80FMI | |
| 8/14/2025 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 87LXH | ARTEMA MEDICAL GROPAKISTAN |
| 7/18/2024 | SYRINGE, PISTON 80FMF | |
| 6/13/2024 | SYRINGE, PISTON 80FMF | |
| 6/13/2024 | SYRINGE, PISTON 80FMF | |
| 6/13/2024 | SYRINGE, PISTON 80FMF | |
| 6/13/2024 | SYRINGE, PISTON 80FMF |
Frequently Asked Questions
What is FDA violation code 3724?
3724 is an FDA violation code that indicates: "The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).". This violation is based on 520(f); 801(a)(1) of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3724?
According to FDA Import Refusal data, there have been 110 import refusals issued for violation code 3724, affecting 29 unique firms.
When was the most recent refusal for violation 3724?
The most recent import refusal for violation 3724 was on December 1, 2025.
What products are commonly refused for violation 3724?
Products commonly refused under violation 3724 include: OXIMETER, INFRARED, SPORTING, AVIATION, MICRO PIPETTE, TOURNIQUET, NONPNEUMATIC, DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3724?
Violation code 3724 is based on 520(f); 801(a)(1) 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.