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Violation Code: 2380

FDA Violation

Charge Code: NO PMA/PDP

283
Total Refusals
175
Affected Firms
10/9/2025
Latest Case
12/7/2001
First Case

Violation Details

Violation Code (ASC ID)
2380
Charge Code
NO PMA/PDP
Description
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Legal Section
501(f)(1)(A); 801(a)(3); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1Edwards Lifesciences AgRio Haina, DOMINICAN 16
2Shanghai Jiu He Import And Export Co.Shanghai, CHINA14
3Q-Med ABUppsala, SWEDEN12
4Baxter Productos Medicos, Ltda.Cartago, COSTA RICA9
5DUFRY CRUISE SERVICES INCMiami, UNITED STA8
6ImasonicVoray Sur L Ognon, FRANCE7
7NIPRO CORP.Odate, JAPAN7
8EQUIDERMAulnay-Sous-Bois, FRANCE6
9INTERVASCULAR, SASLa Ciotat Cedex, FRANCE5
10Immucor, Inc.Peachtree Corners, UNITED STA5
11Nipro Medical Industries, Ltd.Tatebayashi, JAPAN4
12Medical Econet Co LtdSeoul, SOUTH KORE3
13Tae-Chang Industrial Co., Ltd.Gumi, SOUTH KORE3
14P.T. Nipro Indonesia JayaKarawang, INDONESIA3
15FLEXTRONICS (ISRAEL) LTDMigdal Haemek, ISRAEL3
16ORBISAN LTDSan Gwann, MALTA2
17Henan Universe Iol R&M Co LtdHenan, CHINA2
18Good HealthChester, UNITED KIN2
19Alcon Research LLCDuluth, UNITED STA2
20Bio-Tech Vision Care PvtGujarat, INDIA2

Recent Import Refusals

DateProductFirm
10/9/2025
LENSES, SOFT CONTACT, DAILY WEAR
86LPL
DreamCon Co. Ltd.SOUTH KORE
6/11/2025
GENERAL PURPOSE REAGENT
88PPM
ALTRUAN GMBHGERMANY
5/29/2025
CARDIAC ABLATION PERCUTANEOUS CATHETER
74LPB
FLEXTRONICS (ISRAEL) LTDISRAEL
5/29/2025
CARDIAC ABLATION PERCUTANEOUS CATHETER
74LPB
FLEXTRONICS (ISRAEL) LTDISRAEL
5/29/2025
CARDIAC ABLATION PERCUTANEOUS CATHETER
74LPB
FLEXTRONICS (ISRAEL) LTDISRAEL
5/5/2025
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
DERMAX CO LTDCHINA
1/29/2025
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
JETEMA CO LTDSOUTH KORE
12/16/2024
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
Aqtis Medical BvNETHERLAND
5/16/2024
ACID, HYALURONIC, INTRAARTICULAR
87MOZ
PHITOGEN HOLDING SPAITALY
2/9/2024
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
EQUIDERMFRANCE
2/9/2024
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
EQUIDERMFRANCE
2/9/2024
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
EQUIDERMFRANCE
2/9/2024
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
EQUIDERMFRANCE
2/9/2024
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
EQUIDERMFRANCE
2/9/2024
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
EQUIDERMFRANCE

Frequently Asked Questions

What is FDA violation code 2380?

2380 is an FDA violation code that indicates: "The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).". This violation is based on 501(f)(1)(A); 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 2380?

According to FDA Import Refusal data, there have been 283 import refusals issued for violation code 2380, affecting 175 unique firms.

When was the most recent refusal for violation 2380?

The most recent import refusal for violation 2380 was on October 9, 2025.

What products are commonly refused for violation 2380?

Products commonly refused under violation 2380 include: LENSES, SOFT CONTACT, DAILY WEAR, GENERAL PURPOSE REAGENT, CARDIAC ABLATION PERCUTANEOUS CATHETER. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 2380?

Violation code 2380 is based on 501(f)(1)(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.