Dr. Frigz International (Pvt) Ltd.

⚠️ High Risk

FEI: 3003644849 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3003644849

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN

🏢

Address

Airport Road, Gohad Pur, , Sialkot, Punjab, Pakistan

High Risk

FDA Import Risk Assessment

50.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

6/30/2023

Latest Refusal

4/17/2002

Earliest Refusal

Score Breakdown

Violation Severity

64.5×40%

Refusal Volume

46.5×30%

Recency

48.9×20%

Frequency

8.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

4807×

STAINSTEEL

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.

4776×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

Date	Product	Violations	Division
6/30/2023	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	3280FRNMFGREG 476NO REGISTR	Division of Southeast Imports (DSEI)
12/30/2010	76EMSCURETTE, PERIODONTIC	480STAINSTEEL	New York District Office (NYK-DO)
12/30/2010	76EFLFORCEPS, DRESSING, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
12/30/2010	85HDFSPECULUM, VAGINAL, METAL	480STAINSTEEL	New York District Office (NYK-DO)
12/30/2010	78FHQHOLDER, NEEDLE	480STAINSTEEL	New York District Office (NYK-DO)
12/30/2010	76EIGRETRACTOR, ALL TYPES	480STAINSTEEL	New York District Office (NYK-DO)
12/30/2010	79LRWSCISSORS, GENERAL USE, SURGICAL	480STAINSTEEL	New York District Office (NYK-DO)
12/30/2010	79HTDFORCEPS	480STAINSTEEL	New York District Office (NYK-DO)
12/30/2010	79GDZHANDLE, SCALPEL	477HOLES	New York District Office (NYK-DO)
11/3/2010	76EIGRETRACTOR, ALL TYPES	477HOLES	New York District Office (NYK-DO)
11/3/2010	79LRWSCISSORS, GENERAL USE, SURGICAL	477HOLES	New York District Office (NYK-DO)
11/3/2010	79GDZHANDLE, SCALPEL	477HOLES	New York District Office (NYK-DO)
11/3/2010	79HTDFORCEPS	477HOLES	New York District Office (NYK-DO)
11/3/2010	78FHQHOLDER, NEEDLE	477HOLES	New York District Office (NYK-DO)
6/1/2004	79LRWSCISSORS, GENERAL USE, SURGICAL	341REGISTERED	Division of Southeast Imports (DSEI)
10/4/2002	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/17/2002	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Dr. Frigz International (Pvt) Ltd.'s FDA import refusal history?

Dr. Frigz International (Pvt) Ltd. (FEI: 3003644849) has 17 FDA import refusal record(s) in our database, spanning from 4/17/2002 to 6/30/2023.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Dr. Frigz International (Pvt) Ltd.'s FEI number is 3003644849.

What types of violations has Dr. Frigz International (Pvt) Ltd. received?

Dr. Frigz International (Pvt) Ltd. has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Dr. Frigz International (Pvt) Ltd. come from?

All FDA import refusal data for Dr. Frigz International (Pvt) Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.