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Violation Code: 3883

FDA Violation

Charge Code: 708NODFL

21
Total Refusals
14
Affected Firms
1/20/2023
Latest Case
8/17/2018
First Case

Violation Details

Violation Code (ASC ID)
3883
Charge Code
708NODFL
Description
The article lacks an OTC "Drug Facts" label as required by 21 CFR 201.66.
Legal Section
502(c), 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1DS Healthcare Group, Inc. dba DS LaboratoriesDoral, UNITED STA4
2Distribuidora Lagunera del Norte, SA de CVTorreon, MEXICO3
3IMPULSORA INTERVISION S.A DE C.VMonterrey, MEXICO2
4PATANJALI AYURVED LIMITEDHaridwar, INDIA2
5Enprani Co LtdSeoul, SOUTH KORE1
6Guangzhou Jieyi Daily Chemical Products Co., Ltd.Guangzhou, CHINA1
7SIGNALVancouver, CANADA1
8YIWU YIFENG SWPPY CHAIN MANAGE CO .,LTDJiangdong, CHINA1
9SOLUCIONES EN BIOSEGURIDAD AMBIEZapopam Jalisco, MEXICO1
10Zolberg CorporationCavite, PHILIPPINE1
11V-LODGISTIK LTDNovosibirsk, RUSSIA1
12Piramal Pharma LimitedPithampur, INDIA1
13Lights Medical Manufacture Co LtdTianjin, CHINA1
14InnisfreeSeoul, SOUTH KORE1

Recent Import Refusals

DateProductFirm
1/20/2023
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
63RBY04
PATANJALI AYURVED LIMITEDINDIA
1/20/2023
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
63RBY04
PATANJALI AYURVED LIMITEDINDIA
6/17/2022
MINOXIDIL (ANTI-HYPERTENSIVE)
62CBY41
DS Healthcare Group, Inc. dba DS LaboratoriesUNITED STA
6/17/2022
MINOXIDIL (ANTI-HYPERTENSIVE)
62CBY41
DS Healthcare Group, Inc. dba DS LaboratoriesUNITED STA
6/17/2022
MINOXIDIL (ANTI-HYPERTENSIVE)
62CBY41
DS Healthcare Group, Inc. dba DS LaboratoriesUNITED STA
6/17/2022
MINOXIDIL (ANTI-HYPERTENSIVE)
62CBY41
DS Healthcare Group, Inc. dba DS LaboratoriesUNITED STA
6/6/2022
ASTRINGENT/ANTI-PERSPIRANT N.E.C.
62WBY99
Zolberg CorporationPHILIPPINE
4/7/2022
MISCELLANEOUS PATENT MEDICINES, ETC.
66VBY99
V-LODGISTIK LTDRUSSIA
12/6/2021
DISINFECTANT N.E.C.
64ABK99
SOLUCIONES EN BIOSEGURIDAD AMBIEMEXICO
1/5/2021
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HAL05
Distribuidora Lagunera del Norte, SA de CVMEXICO
1/5/2021
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HAL05
Distribuidora Lagunera del Norte, SA de CVMEXICO
1/5/2021
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HAL05
Distribuidora Lagunera del Norte, SA de CVMEXICO
11/13/2020
ANTI-MICROBIAL N.E.C.
62HBL99
IMPULSORA INTERVISION S.A DE C.VMEXICO
11/13/2020
ANTI-MICROBIAL N.E.C.
62HBL99
IMPULSORA INTERVISION S.A DE C.VMEXICO
6/26/2020
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HAL05
YIWU YIFENG SWPPY CHAIN MANAGE CO .,LTDCHINA

Related Violations

Other violations under the same legal section: 502(c), 801(a)(3); MISBRANDING

CodeCharge CodeCases
336INCONSPICU1662

Frequently Asked Questions

What is FDA violation code 3883?

3883 is an FDA violation code that indicates: "The article lacks an OTC "Drug Facts" label as required by 21 CFR 201.66.". This violation is based on 502(c), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3883?

According to FDA Import Refusal data, there have been 21 import refusals issued for violation code 3883, affecting 14 unique firms.

When was the most recent refusal for violation 3883?

The most recent import refusal for violation 3883 was on January 20, 2023.

What products are commonly refused for violation 3883?

Products commonly refused under violation 3883 include: SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC), MINOXIDIL (ANTI-HYPERTENSIVE). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3883?

Violation code 3883 is based on 502(c), 801(a)(3); MISBRANDING 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.