Laboratorio Magnachem International, S.A.
⚠️ Moderate Risk
FEI: 3003320065 • Haina • DOMINICAN REPUBLIC
FEI Number
3003320065
Location
Haina
Country
DOMINICAN REPUBLICAddress
Esq Calle K, Ave Jose Francisco Pena Gomez, Haina, , Dominican Republic
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/27/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/27/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/24/2013 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/24/2013 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 10/16/2009 | 60LDK01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/28/2009 | 60LDK01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/28/2009 | 60LDK01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/14/2005 | 63BBC01ALBUTEROL (BRONCHODILATOR) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/14/2005 | 60MBC06CODEINE SULFATE (ANALGESIC, NARCOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/18/2002 | 61XPA41ACRIVASTINE/PSEUDOEPHEDRINE HCL (ANTI-HISTAMINIC) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 1/18/2002 | 54AYB99VITAMIN, N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Laboratorio Magnachem International, S.A.'s FDA import refusal history?
Laboratorio Magnachem International, S.A. (FEI: 3003320065) has 13 FDA import refusal record(s) in our database, spanning from 1/18/2002 to 7/27/2020.
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. Laboratorio Magnachem International, S.A.'s FEI number is 3003320065.
What types of violations has Laboratorio Magnachem International, S.A. received?
Laboratorio Magnachem International, S.A. has been cited for 4 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 Laboratorio Magnachem International, S.A. come from?
All FDA import refusal data for Laboratorio Magnachem International, S.A. 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.