House Of Surgical

⚠️ Moderate Risk

FEI: 5471 • Sialkot • PAKISTAN

FEI

FEI Number

5471

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN

🏢

Address

P.O. Box 105, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

42.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

12/20/2002

Latest Refusal

12/20/2002

Earliest Refusal

Score Breakdown

Violation Severity

64.0×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

70.0×10%

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

27807×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

1183×

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).

Refusal History

Date	Product	Violations	Division
12/20/2002	79FSMTRAY, SURGICAL, INSTRUMENT	2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
12/20/2002	78GCILARYNGOSCOPE	2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
12/20/2002	80JOKSCISSORS, MEDICAL, DISPOSABLE	2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
12/20/2002	79GENFORCEPS, GENERAL & PLASTIC SURGERY	2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
12/20/2002	76EJPARTICULATORS	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
12/20/2002	76EMJELEVATOR, SURGICAL, DENTAL	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
12/20/2002	76EMNSCALER, PERIODONTIC	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is House Of Surgical's FDA import refusal history?

House Of Surgical (FEI: 5471) has 7 FDA import refusal record(s) in our database, spanning from 12/20/2002 to 12/20/2002.

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. House Of Surgical's FEI number is 5471.

What types of violations has House Of Surgical received?

House Of Surgical has been cited for 2 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 House Of Surgical come from?

All FDA import refusal data for House Of Surgical 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.