Forhan's, Ltd.
⚠️ Moderate Risk
FEI: 3004976694 • Karachi, Sindh • PAKISTAN
FEI Number
3004976694
Location
Karachi, Sindh
Country
PAKISTANAddress
V.M. House, , Karachi, Sindh, Pakistan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/18/2016 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/8/2011 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/28/2005 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 7/28/2005 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Forhan's, Ltd.'s FDA import refusal history?
Forhan's, Ltd. (FEI: 3004976694) has 4 FDA import refusal record(s) in our database, spanning from 7/28/2005 to 4/18/2016.
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. Forhan's, Ltd.'s FEI number is 3004976694.
What types of violations has Forhan's, Ltd. received?
Forhan's, Ltd. has been cited for 5 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 Forhan's, Ltd. come from?
All FDA import refusal data for Forhan's, 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.