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Batleys plc

⚠️ Moderate Risk

FEI: 3004669038 • Coventry, GB-NOTA • UNITED KINGDOM

FEI

FEI Number

3004669038

📍

Location

Coventry, GB-NOTA

🇬🇧
🏢

Address

Gielgud Way, Cross Point, Walsgrave, Coventry, GB-NOTA, United Kingdom

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
1/30/2004
Latest Refusal
3/11/2003
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
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

622×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
1/30/2004
16AEE99FISH, N.E.C.
62NEEDS FCE
New York District Office (NYK-DO)
8/20/2003
16AEE99FISH, N.E.C.
62NEEDS FCE
New York District Office (NYK-DO)
3/11/2003
65RBL18SODIUM BICARBONATE (REPLENISHER)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Batleys plc's FDA import refusal history?

Batleys plc (FEI: 3004669038) has 3 FDA import refusal record(s) in our database, spanning from 3/11/2003 to 1/30/2004.

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. Batleys plc's FEI number is 3004669038.

What types of violations has Batleys plc received?

Batleys plc 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 Batleys plc come from?

All FDA import refusal data for Batleys plc 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.