CHAPTER 2000 INDUSTRIES GH LTD.
⚠️ High Risk
FEI: 3015524677 • Tema • GHANA
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2024 | 62MDJ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is CHAPTER 2000 INDUSTRIES GH LTD.'s FDA import refusal history?
CHAPTER 2000 INDUSTRIES GH LTD. (FEI: 3015524677) has 1 FDA import refusal record(s) in our database, spanning from 5/3/2024 to 5/3/2024.
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. CHAPTER 2000 INDUSTRIES GH LTD.'s FEI number is 3015524677.
What types of violations has CHAPTER 2000 INDUSTRIES GH LTD. received?
CHAPTER 2000 INDUSTRIES GH LTD. 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 CHAPTER 2000 INDUSTRIES GH LTD. come from?
All FDA import refusal data for CHAPTER 2000 INDUSTRIES GH LTD. 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.