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Violation Code: 3874

FDA Violation

Charge Code: 708NEWDRUG

5
Total Refusals
5
Affected Firms
6/16/2022
Latest Case
10/1/2020
First Case

Violation Details

Violation Code (ASC ID)
3874
Charge Code
708NEWDRUG
Description
The article has been determined to be a new drug without an approved new drug application.
Legal Section
505(a), 801(a)(3); UNAPPROVED NEW DRUG

Most Affected Firms

#Firm NameLocationCases
1Kaysersberg Pharmaceuticals SASKaysersberg, FRANCE1
2Boehringer Ingelheim GmbhVienna, AUSTRALIA1
3Astrazeneca Osterreich GmbhVienna, AUSTRIA1
4LES LABORATOIRES SERVIER FRANCEGidy, FRANCE1
5ANINA INNOTHERAPEURICS PVT LTDThane, INDIA1

Recent Import Refusals

DateProductFirm
6/16/2022
MISCELLANEOUS PATENT MEDICINES, ETC.
66VDY99
ANINA INNOTHERAPEURICS PVT LTDINDIA
12/4/2020
ANTI-DEPRESSANT N.E.C.
61NDB99
LES LABORATOIRES SERVIER FRANCEFRANCE
11/9/2020
HYDROXYPROPYL CELLULOSE (PROTECTANT)
65LDK16
Kaysersberg Pharmaceuticals SASFRANCE
10/1/2020
TELMISARTAN (ANTI-HYPERTENSIVE - PART II)
62OCB09
Boehringer Ingelheim GmbhAUSTRALIA
10/1/2020
ROSUVASTATIN CALCIUM
61JCH16
Astrazeneca Osterreich GmbhAUSTRIA

Related Violations

Other violations under the same legal section: 505(a), 801(a)(3); UNAPPROVED NEW DRUG

CodeCharge CodeCases
75UNAPPROVED73905

Frequently Asked Questions

What is FDA violation code 3874?

3874 is an FDA violation code that indicates: "The article has been determined to be a new drug without an approved new drug application.". This violation is based on 505(a), 801(a)(3); UNAPPROVED NEW DRUG of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3874?

According to FDA Import Refusal data, there have been 5 import refusals issued for violation code 3874, affecting 5 unique firms.

When was the most recent refusal for violation 3874?

The most recent import refusal for violation 3874 was on June 16, 2022.

What products are commonly refused for violation 3874?

Products commonly refused under violation 3874 include: MISCELLANEOUS PATENT MEDICINES, ETC., ANTI-DEPRESSANT N.E.C., HYDROXYPROPYL CELLULOSE (PROTECTANT), TELMISARTAN (ANTI-HYPERTENSIVE - PART II), ROSUVASTATIN CALCIUM. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3874?

Violation code 3874 is based on 505(a), 801(a)(3); UNAPPROVED NEW DRUG 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.