ImportRefusal LogoImportRefusal

Violation Code: 3873

FDA Violation

Charge Code: 708NOREG

26
Total Refusals
19
Affected Firms
6/7/2022
Latest Case
4/19/2016
First Case

Violation Details

Violation Code (ASC ID)
3873
Charge Code
708NOREG
Description
It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Legal Section
502(o), 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1KUNSHAN HEALTH & BEYONDKunshan, CHINA3
2Ezekiel Cosmetics Co.Incheon, SOUTH KORE3
3Genfar S ABogota, COLOMBIA2
4Guangzhou Shiruoni Cosmetics Co., LtdGuangzhou, CHINA2
5MyvitalyMontebelluna, ITALY2
6GUANGZHOU UFEIYA METAL PRODUCTSCO. LTDGuangzhou, CHINA1
7Hangzhou Caring Cleaning Commodity Co., LtdHangzhou, CHINA1
8LABORATORIOS SYNTHESIS S A SBogota, COLOMBIA1
9MERCK & SHARP & DOHME COLOMBIABogota, COLOMBIA1
10RIFEXJakarta, INDONESIA1
11SIGFRIEDBogota, COLOMBIA1
12SIGMA INK S DE RL DE CVTijuana, MEXICO1
13Singwong Asia Pacific (Boluo) Co., LtdHuizhou, CHINA1
14Aayu ImpexMumbai, INDIA1
15THAI MINH PHARMACEUTICALHa Noi, VIETNAM1
16Anqiu Lu'an Pharmaceutical Co., Ltd.Weifang, CHINA1
17CHRISAL NEDERLANDBoskoop, NETHERLAND1
18FABRICADO POR MERCK SHARP DOHMEBogota, COLOMBIA1
19GENBODY INCCheonan, SOUTH KORE1

Recent Import Refusals

DateProductFirm
6/7/2022
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HAK05
CHRISAL NEDERLANDNETHERLAND
5/19/2022
SALICYLIC ACID (KERATOLYTIC)
64XAJ06
Hangzhou Caring Cleaning Commodity Co., LtdCHINA
4/9/2021
ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
62FAL23
Singwong Asia Pacific (Boluo) Co., LtdCHINA
4/2/2021
ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
62FAL23
GUANGZHOU UFEIYA METAL PRODUCTSCO. LTDCHINA
2/23/2021
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HAL05
Guangzhou Shiruoni Cosmetics Co., LtdCHINA
2/23/2021
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HAL05
Guangzhou Shiruoni Cosmetics Co., LtdCHINA
2/16/2021
REAGENT, CORONAVIRUS SEROLOGICAL
83QKO
GENBODY INCSOUTH KORE
2/1/2021
BOTOX
65QDT02
RIFEXINDONESIA
12/4/2020
SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
61PCA68
FABRICADO POR MERCK SHARP DOHMECOLOMBIA
12/4/2020
REGULATOR N.E.C.
65PCA99
Genfar S ACOLOMBIA
12/4/2020
TAMSULOSIN HCL (REGULATOR)
65PCA03
Genfar S ACOLOMBIA
12/4/2020
LEVOTHYROXINE SODIUM (THYROID HORMONE)
66JCA01
MERCK & SHARP & DOHME COLOMBIACOLOMBIA
12/4/2020
METFORMIN HCL (ANTI-DIABETIC)
61PCA55
SIGFRIEDCOLOMBIA
12/4/2020
ROSUVASTATIN CALCIUM
61JDA16
LABORATORIOS SYNTHESIS S A SCOLOMBIA
11/17/2020
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HAL05
MyvitalyITALY

Related Violations

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

CodeCharge CodeCases
118NOT LISTED133902
3280FRNMFGREG30787
341REGISTERED21690
3872708LISTING13

Frequently Asked Questions

What is FDA violation code 3873?

3873 is an FDA violation code that indicates: "It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.". This violation is based on 502(o), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3873?

According to FDA Import Refusal data, there have been 26 import refusals issued for violation code 3873, affecting 19 unique firms.

When was the most recent refusal for violation 3873?

The most recent import refusal for violation 3873 was on June 7, 2022.

What products are commonly refused for violation 3873?

Products commonly refused under violation 3873 include: ETHYL ALCOHOL (ANTI-MICROBIAL), SALICYLIC ACID (KERATOLYTIC), ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3873?

Violation code 3873 is based on 502(o), 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.