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Shire Human Genetic Therapies, Inc.

⚠️ Moderate Risk

FEI: 3009340644 • Lexington, MA • UNITED STATES

FEI

FEI Number

3009340644

📍

Location

Lexington, MA

🇺🇸
🏢

Address

200, 300, 400 Shire Way, , Lexington, MA, United States

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
12/4/2018
Latest Refusal
12/4/2018
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
12/4/2018
66BCY99STIMULANT N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Shire Human Genetic Therapies, Inc.'s FDA import refusal history?

Shire Human Genetic Therapies, Inc. (FEI: 3009340644) has 1 FDA import refusal record(s) in our database, spanning from 12/4/2018 to 12/4/2018.

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. Shire Human Genetic Therapies, Inc.'s FEI number is 3009340644.

What types of violations has Shire Human Genetic Therapies, Inc. received?

Shire Human Genetic Therapies, Inc. 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 Shire Human Genetic Therapies, Inc. come from?

All FDA import refusal data for Shire Human Genetic Therapies, Inc. 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.