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Sterling Pharmacy Ltd

⚠️ Moderate Risk

FEI: 3010976484 • West Didsbury • UNITED KINGDOM

FEI

FEI Number

3010976484

📍

Location

West Didsbury

🇬🇧
🏢

Address

Lapwing Lane 103, , West Didsbury, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

30.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
4
Unique Violations
10/27/2014
Latest Refusal
9/24/2014
Earliest Refusal

Score Breakdown

Violation Severity
58.0×40%
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

1182×

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).

3431×

VET LEGEND

The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).

35001×

RXLABEL

The labeling fails to bear, at a minimum, the symbol "RX Only".

721×

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
10/27/2014
62GQO90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
118NOT LISTED
343VET LEGEND
3500RXLABEL
72NEW VET DR
Los Angeles District Office (LOS-DO)
9/24/2014
60QBO99ANESTHETIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sterling Pharmacy Ltd's FDA import refusal history?

Sterling Pharmacy Ltd (FEI: 3010976484) has 2 FDA import refusal record(s) in our database, spanning from 9/24/2014 to 10/27/2014.

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. Sterling Pharmacy Ltd's FEI number is 3010976484.

What types of violations has Sterling Pharmacy Ltd received?

Sterling Pharmacy Ltd has been cited for 4 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 Sterling Pharmacy Ltd come from?

All FDA import refusal data for Sterling Pharmacy 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.