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A1 Pharmaceuticals Plc

✅ Low Risk

FEI: 3008323711 • Rainham, Essex • UNITED KINGDOM

FEI

FEI Number

3008323711

📍

Location

Rainham, Essex

🇬🇧
🏢

Address

Unit 20/21 Easter Park, Ferry Lane, Rainham, Essex, United Kingdom

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
5/24/2019
Latest Refusal
5/24/2019
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
5/24/2019
75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is A1 Pharmaceuticals Plc's FDA import refusal history?

A1 Pharmaceuticals Plc (FEI: 3008323711) has 1 FDA import refusal record(s) in our database, spanning from 5/24/2019 to 5/24/2019.

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. A1 Pharmaceuticals Plc's FEI number is 3008323711.

What types of violations has A1 Pharmaceuticals Plc received?

A1 Pharmaceuticals 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 A1 Pharmaceuticals Plc come from?

All FDA import refusal data for A1 Pharmaceuticals 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.