M & A International
⚠️ Moderate Risk
FEI: 3004470767 • Karachi • PAKISTAN
FEI Number
3004470767
Location
Karachi
Country
PAKISTANAddress
Business Plaza 9th Floor Roomno. 902, , Karachi, , 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
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).
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/25/2016 | 54IGT99FIBER, N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/6/2010 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/6/2010 | 61FBK21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 10/7/2009 | 21HGT01APRICOT, DRIED OR PASTE | 249FILTHY | New York District Office (NYK-DO) |
Frequently Asked Questions
What is M & A International's FDA import refusal history?
M & A International (FEI: 3004470767) has 4 FDA import refusal record(s) in our database, spanning from 10/7/2009 to 1/25/2016.
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. M & A International's FEI number is 3004470767.
What types of violations has M & A International received?
M & A International 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 M & A International come from?
All FDA import refusal data for M & A International 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.