Violation Code: 2780
FDA Violation
Charge Code: DEVICEGMPS
Violation Details
- Violation Code (ASC ID)
- 2780
- Charge Code
- DEVICEGMPS
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
- Legal Section
- 501(h), 801(a)(1); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Shanghai Kindly Enterprise Development Group Co., Ltd | Jiading, CHINA | 1052 |
| 2 | Jiangsu Caina Medical Co., Ltd | Wuxi, CHINA | 270 |
| 3 | Tinopal Surgical Corp. (Pvt) Ltd. | Sialkot, PAKISTAN | 110 |
| 4 | Covidien | Juarez, MEXICO | 103 |
| 5 | Edwards Lifesciences | Bajos De Haina, DOMINICAN | 85 |
| 6 | Merits Health Products Co., Ltd. | Taichung City, TAIWAN | 84 |
| 7 | K Plus International | Sialkot, PAKISTAN | 63 |
| 8 | Invatec Innovative Technologies S.P.A. | Roncadelle, ITALY | 55 |
| 9 | Interojo Inc. | Pyeongtaek City, SOUTH KORE | 50 |
| 10 | Puretone Ltd. | Rochester, UNITED KIN | 32 |
| 11 | Oridion Medical 1987 Ltd. | Jerusalem, ISRAEL | 31 |
| 12 | P.T. Nipro Indonesia Jaya | Karawang, INDONESIA | 29 |
| 13 | Jiangsu Shenli Medical Production Co., Ltd. | Changzhou, CHINA | 28 |
| 14 | Mount Blonck Trading | Sialkot, PAKISTAN | 28 |
| 15 | Gsell Medical Plastics Ag | Muri AG, SWITZERLAN | 27 |
| 16 | Westmed De Mexico S.A. De C.V. | Tecate, MEXICO | 27 |
| 17 | Convertors De Mexico | Juarez, MEXICO | 23 |
| 18 | QUASAR ENGINEERING LTD. | Hong Kong, CHINA | 23 |
| 19 | Zibo Hengde Plastic & Rubber Products Co., Ltd. | Zibo, CHINA | 21 |
| 20 | TECNO INSTRUMENTS (PVT.) LTD. | Sialkot, PAKISTAN | 21 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/4/2025 | OXIMETER 73DQA | |
| 11/26/2025 | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 74DXN | |
| 11/17/2025 | SET, DIALYSIS, SINGLE NEEDLE WITH UNI-DIRECTIONAL PUMP 78FIF | P.T. Nipro Indonesia JayaINDONESIA |
| 10/28/2025 | URETEROSCOPE 78FGB | |
| 10/20/2025 | PUMP, INFUSION, ELASTOMERIC 80MEB | NIPRO CORP.JAPAN |
| 10/20/2025 | PURIFIER, WATER (ABSORPTION, DEIONIZATION, MEMBRANE FILTER, REVERSE OSMOSIS) 75JRS | NIPRO CORP.JAPAN |
| 10/20/2025 | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM 78KDI | NIPRO CORP.JAPAN |
| 10/20/2025 | WIRE, GUIDE, CATHETER 74DQX | |
| 10/20/2025 | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) 73BSP | |
| 10/8/2025 | NEEDLE, HYPODERMIC, SINGLE LUMEN 80FMI | RIMOS SRLITALY |
| 10/8/2025 | NEEDLE, HYPODERMIC, SINGLE LUMEN 80FMI | RIMOS SRLITALY |
| 10/6/2025 | STRIP, SCHIRMER 86KYD | |
| 8/15/2025 | SCRAPER, TONGUE 76LCN | ALIENS INTERNATIONALPAKISTAN |
| 8/15/2025 | SCALER, PERIODONTIC 76EMN | ALIENS INTERNATIONALPAKISTAN |
| 8/15/2025 | PROBE, PERIODONTIC 76EIX | ALIENS INTERNATIONALPAKISTAN |
Frequently Asked Questions
What is FDA violation code 2780?
2780 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act. ". This violation is based on 501(h), 801(a)(1); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2780?
According to FDA Import Refusal data, there have been 3113 import refusals issued for violation code 2780, affecting 310 unique firms.
When was the most recent refusal for violation 2780?
The most recent import refusal for violation 2780 was on December 4, 2025.
What products are commonly refused for violation 2780?
Products commonly refused under violation 2780 include: OXIMETER, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, SET, DIALYSIS, SINGLE NEEDLE WITH UNI-DIRECTIONAL PUMP, URETEROSCOPE, PUMP, INFUSION, ELASTOMERIC. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2780?
Violation code 2780 is based on 501(h), 801(a)(1); 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.