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Apollo Scientific

⚠️ Moderate Risk

FEI: 3008091410 • Manchester • UNITED KINGDOM

FEI

FEI Number

3008091410

📍

Location

Manchester

🇬🇧
🏢

Address

Unit 3 & 4 Parkway, , Manchester, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/16/2016
Latest Refusal
3/16/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

163×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
3/16/2016
55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
16DIRECTIONS
Division of Northern Border Imports (DNBI)
3/16/2016
55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
16DIRECTIONS
Division of Northern Border Imports (DNBI)
3/16/2016
55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
16DIRECTIONS
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Apollo Scientific's FDA import refusal history?

Apollo Scientific (FEI: 3008091410) has 3 FDA import refusal record(s) in our database, spanning from 3/16/2016 to 3/16/2016.

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. Apollo Scientific's FEI number is 3008091410.

What types of violations has Apollo Scientific received?

Apollo Scientific 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 Apollo Scientific come from?

All FDA import refusal data for Apollo Scientific 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.