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Biosil, Ltd.

⚠️ Moderate Risk

FEI: 3002806532 • Glasgow • UNITED KINGDOM

FEI

FEI Number

3002806532

📍

Location

Glasgow

🇬🇧
🏢

Address

127 Deerdykes View, Westfield Ind Estate, Glasgow, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/8/2002
Latest Refusal
4/8/2002
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

27802×

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
4/8/2002
79FWMPROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
2780DEVICEGMPS
Cincinnati District Office (CIN-DO)
4/8/2002
79FWMPROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
2780DEVICEGMPS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Biosil, Ltd.'s FDA import refusal history?

Biosil, Ltd. (FEI: 3002806532) has 2 FDA import refusal record(s) in our database, spanning from 4/8/2002 to 4/8/2002.

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. Biosil, Ltd.'s FEI number is 3002806532.

What types of violations has Biosil, Ltd. received?

Biosil, Ltd. 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 Biosil, Ltd. come from?

All FDA import refusal data for Biosil, 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.