Atlantic Exports
⚠️ Moderate Risk
FEI: 1000291448 • Mumbai • INDIA
FEI Number
1000291448
Location
Mumbai
Country
INDIAAddress
A-8 Shah & Nahar, Unit 111, Ist Floor, Mumbai, , 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
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.
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).
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.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/6/2003 | 25HEE99MIXED VEGETABLES, WITH SAUCE, N.E.C. | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 5/19/2003 | 60SBL09DIHYDROXYALUM SODIUM CARBONATE (ANTACID) | Chicago District Office (CHI-DO) | |
| 4/30/2003 | 03MGY99COOKIE,BISCUIT,WAFER DOUGH, N.E.C. | 249FILTHY | Chicago District Office (CHI-DO) |
| 4/30/2003 | 60SBL09DIHYDROXYALUM SODIUM CARBONATE (ANTACID) | Chicago District Office (CHI-DO) | |
| 8/14/2002 | 09YGT99FLUID/DRY MILK PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | 482NUTRIT LBL | Chicago District Office (CHI-DO) |
| 8/14/2002 | 60SAA99ANTACID, N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 8/14/2002 | 60SAA99ANTACID, N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 4/12/2002 | 21TGT14TAMARIND, DRIED OR PASTE | 249FILTHY | Chicago District Office (CHI-DO) |
| 1/2/2002 | 03MGY99COOKIE,BISCUIT,WAFER DOUGH, N.E.C. | 249FILTHY | Chicago District Office (CHI-DO) |
| 1/2/2002 | 03YGY99OTHER BAKERY PRODUCTS, N.E.C. | 249FILTHY | Chicago District Office (CHI-DO) |
| 10/26/2001 | 03YGT99OTHER BAKERY PRODUCTS, N.E.C. | 249FILTHY | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Atlantic Exports's FDA import refusal history?
Atlantic Exports (FEI: 1000291448) has 11 FDA import refusal record(s) in our database, spanning from 10/26/2001 to 10/6/2003.
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. Atlantic Exports's FEI number is 1000291448.
What types of violations has Atlantic Exports received?
Atlantic Exports 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 Atlantic Exports come from?
All FDA import refusal data for Atlantic Exports 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.