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Catalent UK Swindon Encaps Limited

⚠️ Moderate Risk

FEI: 3006412268 • Swindon, Wiltshire • UNITED KINGDOM

FEI

FEI Number

3006412268

📍

Location

Swindon, Wiltshire

🇬🇧
🏢

Address

Frankland Road, , Swindon, Wiltshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/24/2014
Latest Refusal
11/24/2014
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Catalent UK Swindon Encaps Limited's FDA import refusal history?

Catalent UK Swindon Encaps Limited (FEI: 3006412268) has 1 FDA import refusal record(s) in our database, spanning from 11/24/2014 to 11/24/2014.

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. Catalent UK Swindon Encaps Limited's FEI number is 3006412268.

What types of violations has Catalent UK Swindon Encaps Limited received?

Catalent UK Swindon Encaps Limited 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 Catalent UK Swindon Encaps Limited come from?

All FDA import refusal data for Catalent UK Swindon Encaps Limited 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.