Alchem International Ltd.
⚠️ Moderate Risk
FEI: 3003310718 • Faridabad, Haryana • INDIA
FEI Number
3003310718
Location
Faridabad, Haryana
Country
INDIAAddress
25/2 Mathura Road, Ballabgarh, Village Kaili, Faridabad, Haryana, India
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/19/2014 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/13/2012 | 66BAK44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/6/2012 | 66BAK44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/6/2010 | 60CAS99ADRENERGIC N.E.C. | Cincinnati District Office (CIN-DO) | |
| 4/30/2009 | 66BIY44NICOTINE DELIVERY SYSTEM | Chicago District Office (CHI-DO) | |
| 7/14/2006 | 61KCS26HYOSCYAMINE HYDROBROMIDE (ANTI-CHOLINERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/10/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/22/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/22/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/25/2002 | 63HCS23SENNOSIDES A AND B (CATHARTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Alchem International Ltd.'s FDA import refusal history?
Alchem International Ltd. (FEI: 3003310718) has 10 FDA import refusal record(s) in our database, spanning from 7/25/2002 to 9/19/2014.
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. Alchem International Ltd.'s FEI number is 3003310718.
What types of violations has Alchem International Ltd. received?
Alchem International Ltd. has been cited for 3 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 Alchem International Ltd. come from?
All FDA import refusal data for Alchem International 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.