ImportRefusal LogoImportRefusal

Violation Code: 290

FDA Violation

Charge Code: DE IMP GMP

1,988
Total Refusals
353
Affected Firms
12/17/2025
Latest Case
10/15/2001
First Case

Violation Details

Violation Code (ASC ID)
290
Charge Code
DE IMP GMP
Description
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Legal Section
801(a)(1); NON CONFORMING MANUFACTURING PRACTICES

Most Affected Firms

#Firm NameLocationCases
1Tinopal Surgical Corp. (Pvt) Ltd.Sialkot, PAKISTAN387
2Merits Health Products Co., Ltd.Taichung City, TAIWAN193
3Convertors De MexicoJuarez, MEXICO119
4Washington Surgical InternationalSialkot, PAKISTAN54
5K T Surgico (PVT) Ltd.Sialkot, PAKISTAN44
6Shanghai Multi-Med Union Co., LtdShanghai, CHINA39
7AAKK SURGICAL CORPORATIONSialkot, PAKISTAN39
8Blacksmith SurgicaKarachi, PAKISTAN33
9K Plus InternationalSialkot, PAKISTAN31
10Diligent Medical ServicesSialkot, PAKISTAN29
11Garana IndustriesSialkot, PAKISTAN26
12Faizan SurgicalSialkot, PAKISTAN19
13Quality Point InternationalSialkot, PAKISTAN18
14Y.Z. CorporationSialkot, PAKISTAN18
15Productos Medline, S.A. de C.V.Nuevo Laredo, MEXICO17
16N.D. Surgical IndustriesSialkot, PAKISTAN17
17Sobytex InstSialkot, PAKISTAN17
18MEDIZOLE ENTERPRISESSialkota, PAKISTAN17
19SIMRIX Surgical Co.Sialkot, PAKISTAN16
20Renix IntlSialkot, PAKISTAN14

Recent Import Refusals

DateProductFirm
12/17/2025
HEMOSTAT
79HRQ
Washington Surgical InternationalPAKISTAN
12/12/2025
FORCEPS, GENERAL & PLASTIC SURGERY
79GEN
Washington Surgical InternationalPAKISTAN
12/5/2025
SCISSORS, GENERAL USE, SURGICAL
79LRW
Washington Surgical InternationalPAKISTAN
12/5/2025
HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
79GDG
Washington Surgical InternationalPAKISTAN
12/3/2025
HOLDER, NEEDLE
78FHQ
Washington Surgical InternationalPAKISTAN
12/2/2025
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
79GEA
SAAMS INSTRUMENTSPAKISTAN
11/28/2025
HAMMER, SURGICAL
79FZY
FIRST MED INSTRUMENTSPAKISTAN
11/19/2025
SET, AUDIOMETER CALIBRATION
77EWA
CATAMOUNTPAKISTAN
11/19/2025
SET, AUDIOMETER CALIBRATION
77EWA
CATAMOUNTPAKISTAN
11/19/2025
SET, AUDIOMETER CALIBRATION
77EWA
CATAMOUNTPAKISTAN
11/19/2025
SET, AUDIOMETER CALIBRATION
77EWA
CATAMOUNTPAKISTAN
11/19/2025
SCISSORS, GENERAL USE, SURGICAL
79LRW
SURGILINKS MEDICAL SERVICESPAKISTAN
11/17/2025
FORCEPS, GENERAL & PLASTIC SURGERY
79GEN
Washington Surgical InternationalPAKISTAN
11/12/2025
STERILANT, MEDICAL DEVICES
80MED
Washington Surgical InternationalPAKISTAN
11/6/2025
SCISSORS, GENERAL USE, SURGICAL
79LRW
Washington Surgical InternationalPAKISTAN

Frequently Asked Questions

What is FDA violation code 290?

290 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).". This violation is based on 801(a)(1); NON CONFORMING MANUFACTURING PRACTICES of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 290?

According to FDA Import Refusal data, there have been 1988 import refusals issued for violation code 290, affecting 353 unique firms.

When was the most recent refusal for violation 290?

The most recent import refusal for violation 290 was on December 17, 2025.

What products are commonly refused for violation 290?

Products commonly refused under violation 290 include: HEMOSTAT, FORCEPS, GENERAL & PLASTIC SURGERY, SCISSORS, GENERAL USE, SURGICAL, HOOK, SURGICAL, GENERAL & PLASTIC SURGERY, HOLDER, NEEDLE. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 290?

Violation code 290 is based on 801(a)(1); NON CONFORMING MANUFACTURING PRACTICES 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.