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Boiron Inc.

⚠️ Moderate Risk

FEI: 2510831 • Newtown Square, PA • UNITED STATES

FEI

FEI Number

2510831

📍

Location

Newtown Square, PA

🇺🇸
🏢

Address

6 Campus Blvd, , Newtown Square, PA, United States

Moderate Risk

FDA Import Risk Assessment

40.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
7/22/2019
Latest Refusal
9/21/2018
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
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

752×

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).

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
7/22/2019
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/14/2019
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
260FALSE
Division of West Coast Imports (DWCI)
9/21/2018
66MBY99TRANQUILIZER N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Boiron Inc.'s FDA import refusal history?

Boiron Inc. (FEI: 2510831) has 3 FDA import refusal record(s) in our database, spanning from 9/21/2018 to 7/22/2019.

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. Boiron Inc.'s FEI number is 2510831.

What types of violations has Boiron Inc. received?

Boiron Inc. 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 Boiron Inc. come from?

All FDA import refusal data for Boiron 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.