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CALLINOVA

⚠️ Moderate Risk

FEI: 3016571408 • Nailsworth • UNITED KINGDOM

FEI

FEI Number

3016571408

📍

Location

Nailsworth

🇬🇧
🏢

Address

21 22 Spring Mill, , Nailsworth, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/11/2022
Latest Refusal
3/11/2022
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
8.2×20%
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

723×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
3/11/2022
61HOL99ANTI-BACTERIAL, N.E.C.
72NEW VET DR
Division of West Coast Imports (DWCI)
3/11/2022
60ZOL04AMPROLIUM (ANTIPARASITIC)
72NEW VET DR
Division of West Coast Imports (DWCI)
3/11/2022
60ZOL04AMPROLIUM (ANTIPARASITIC)
72NEW VET DR
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is CALLINOVA's FDA import refusal history?

CALLINOVA (FEI: 3016571408) has 3 FDA import refusal record(s) in our database, spanning from 3/11/2022 to 3/11/2022.

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. CALLINOVA's FEI number is 3016571408.

What types of violations has CALLINOVA received?

CALLINOVA 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 CALLINOVA come from?

All FDA import refusal data for CALLINOVA 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.