ImportRefusal LogoImportRefusal

Nobby Medical Instruments

⚠️ Moderate Risk

FEI: 3004145466 • Sialkot • PAKISTAN

FEI

FEI Number

3004145466

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Muhalla Gelani, Gohad Pur, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

50.0
LowModerateHighCritical

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

Statistics

11
Total Refusals
1
Unique Violations
12/16/2008
Latest Refusal
4/10/2008
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

278011×

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.

Refusal History

DateProductViolationsDivision
12/16/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
12/16/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
12/16/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
12/16/2008
76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL
2780DEVICEGMPS
Seattle District Office (SEA-DO)
12/16/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
12/16/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
12/16/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
12/16/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
12/16/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
4/10/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)
4/10/2008
76EMNSCALER, PERIODONTIC
2780DEVICEGMPS
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Nobby Medical Instruments's FDA import refusal history?

Nobby Medical Instruments (FEI: 3004145466) has 11 FDA import refusal record(s) in our database, spanning from 4/10/2008 to 12/16/2008.

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. Nobby Medical Instruments's FEI number is 3004145466.

What types of violations has Nobby Medical Instruments received?

Nobby Medical Instruments has been cited for 1 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 Nobby Medical Instruments come from?

All FDA import refusal data for Nobby Medical Instruments 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.