ImportRefusal LogoImportRefusal

Violation Code: 480

FDA Violation

Charge Code: STAINSTEEL

1,117
Total Refusals
191
Affected Firms
6/2/2017
Latest Case
11/1/2001
First Case

Violation Details

Violation Code (ASC ID)
480
Charge Code
STAINSTEEL
Description
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
Legal Section
501(c); 801(a)(3) Adulteration

Most Affected Firms

#Firm NameLocationCases
1M/S. Mibe CorporationSialkot, PAKISTAN87
2SEASONED SURGICALPRODUCTSSialkot, PAKISTAN70
3Tinopal Surgical Corp. (Pvt) Ltd.Sialkot, PAKISTAN57
4CovidienTijuana, MEXICO34
5Acme EnterprisesSialkot, PAKISTAN31
6K Plus InternationalSialkot, PAKISTAN30
7A.N.A. Amity ImpexSialkot, PAKISTAN27
8Mua Ortho Dentics SupplySialkot, PAKISTAN26
9Commic SurgicoSialkot, PAKISTAN24
10Muhkam Trading CorporporationSialkot, PAKISTAN23
11M/s Hi Tech InternationalSialkot, PAKISTAN21
12Concise EnterprisesSialkot, PAKISTAN21
13Best DealsSialkot, PAKISTAN20
14Stone Instruments CompanySialkot, PAKISTAN19
15Bestech InternationalSialkot, PAKISTAN17
16Ibi InstrumentsSialkot, PAKISTAN17
17Aemco Z.E. (PVT) Ltd.Sialkot-3, PAKISTAN16
18Hitter ImpexSailkot, PAKISTAN16
19DentechSialkot, PAKISTAN16
20SurgikareSialkot, PAKISTAN15

Recent Import Refusals

DateProductFirm
6/2/2017
FORCEPS
79HTD
ZEESHAN AND RIZWAN INTERNATIONALPAKISTAN
3/3/2017
SCALER, ROTARY
76ELB
NUTLINK INTERNATIONALPAKISTAN
3/3/2017
RETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY
79GAD
NUTLINK INTERNATIONALPAKISTAN
3/3/2017
PLIERS, SURGICAL
79HTC
NUTLINK INTERNATIONALPAKISTAN
3/3/2017
DRESS, SURGICAL
79FYE
NUTLINK INTERNATIONALPAKISTAN
3/3/2017
SCISSORS, GENERAL USE, SURGICAL
79LRW
NUTLINK INTERNATIONALPAKISTAN
3/3/2017
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
79GFF
NUTLINK INTERNATIONALPAKISTAN
2/3/2017
PROBE
87HXB
Mount Blonck TradingPAKISTAN
2/3/2017
ELEVATOR, SURGICAL, DENTAL
76EMJ
Mount Blonck TradingPAKISTAN
2/3/2017
SCISSORS, MEDICAL, DISPOSABLE
80JOK
Mount Blonck TradingPAKISTAN
2/3/2017
FORCEPS, GENERAL & PLASTIC SURGERY
79GEN
Mount Blonck TradingPAKISTAN
6/6/2016
SCISSORS, GENERAL USE, SURGICAL
79LRW
Tinopal Surgical Corp. (Pvt) Ltd.PAKISTAN
6/6/2016
NIPPER, MALLEUS
77JYR
Tinopal Surgical Corp. (Pvt) Ltd.PAKISTAN
6/6/2016
FORCEPS, GENERAL & PLASTIC SURGERY
79GEN
Tinopal Surgical Corp. (Pvt) Ltd.PAKISTAN
6/6/2016
FORCEPS, GENERAL & PLASTIC SURGERY
79GEN
Tinopal Surgical Corp. (Pvt) Ltd.PAKISTAN

Related Violations

Other violations under the same legal section: 501(c); 801(a)(3) Adulteration

CodeCharge CodeCases
477HOLES2799
479DV QUALITY1383
3380EXPIRED145

Frequently Asked Questions

What is FDA violation code 480?

480 is an FDA violation code that indicates: "The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.". This violation is based on 501(c); 801(a)(3) Adulteration of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 480?

According to FDA Import Refusal data, there have been 1117 import refusals issued for violation code 480, affecting 191 unique firms.

When was the most recent refusal for violation 480?

The most recent import refusal for violation 480 was on June 2, 2017.

What products are commonly refused for violation 480?

Products commonly refused under violation 480 include: FORCEPS, SCALER, ROTARY, RETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY, PLIERS, SURGICAL, DRESS, SURGICAL. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 480?

Violation code 480 is based on 501(c); 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.