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BAYER HEALTHCARE LIMITED

⚠️ Moderate Risk

FEI: 3018525625 • Quarry Bay, Hong Kong Island • HONG KONG

FEI

FEI Number

3018525625

📍

Location

Quarry Bay, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

14/F, Taikoo Place Oxford House; 979 King'S Road; Hong Kong, Quarry Bay, Hong Kong Island, Hong Kong

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
5/17/2021
Latest Refusal
5/17/2021
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
5/17/2021
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BAYER HEALTHCARE LIMITED's FDA import refusal history?

BAYER HEALTHCARE LIMITED (FEI: 3018525625) has 1 FDA import refusal record(s) in our database, spanning from 5/17/2021 to 5/17/2021.

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. BAYER HEALTHCARE LIMITED's FEI number is 3018525625.

What types of violations has BAYER HEALTHCARE LIMITED received?

BAYER HEALTHCARE 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 BAYER HEALTHCARE LIMITED come from?

All FDA import refusal data for BAYER HEALTHCARE 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.