Charleswell Ent
⚠️ High Risk
FEI: 3006010948 • Accra • 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 1/16/2007 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 63VAL02HYDROQUINONE (DEPIGMENTOR) | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 65PCB02SILDENAFIL CITRATE (REGULATOR) | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 66VDH99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 64LCY06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Charleswell Ent's FDA import refusal history?
Charleswell Ent (FEI: 3006010948) has 9 FDA import refusal record(s) in our database, spanning from 1/16/2007 to 1/16/2007.
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. Charleswell Ent's FEI number is 3006010948.
What types of violations has Charleswell Ent received?
Charleswell Ent 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 Charleswell Ent come from?
All FDA import refusal data for Charleswell Ent 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.