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Oral-B Laboratories, Inc.

⚠️ Moderate Risk

FEI: 1000166169 • Redwood City, CA • UNITED STATES

FEI

FEI Number

1000166169

📍

Location

Redwood City, CA

🇺🇸
🏢

Address

1 Lagoon Dr, , Redwood City, CA, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/11/2003
Latest Refusal
9/11/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1791×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

DateProductViolationsDivision
9/11/2003
63RDY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
179AGR RX
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Oral-B Laboratories, Inc.'s FDA import refusal history?

Oral-B Laboratories, Inc. (FEI: 1000166169) has 1 FDA import refusal record(s) in our database, spanning from 9/11/2003 to 9/11/2003.

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. Oral-B Laboratories, Inc.'s FEI number is 1000166169.

What types of violations has Oral-B Laboratories, Inc. received?

Oral-B Laboratories, 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 Oral-B Laboratories, Inc. come from?

All FDA import refusal data for Oral-B Laboratories, 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.