Ami
⚠️ Moderate Risk
FEI: 3002082544 • Stanwell • UNITED KINGDOM
FEI Number
3002082544
Location
Stanwell
Country
UNITED KINGDOMAddress
6 Blackburn Trading, , Stanwell, , United Kingdom
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).
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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).
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2006 | 54AYY99VITAMIN, N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 7/21/2005 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/4/2005 | 85HISCONDOM | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 2/14/2005 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 1/6/2005 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 8/24/2004 | 41DYY99FOODS WITH CLAIMS RELATED TO FAT, FATTY ACID AND/OR CHOLESTEROL CONTENT | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 2/4/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/4/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/15/2003 | 54AYY99VITAMIN, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/8/2003 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | New Orleans District Office (NOL-DO) | |
| 7/2/2003 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/15/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 12/17/2002 | 54AYY99VITAMIN, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/19/2002 | 79LRRKIT, FIRST AID | New York District Office (NYK-DO) | |
| 2/24/2002 | 16AEY45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) | 62NEEDS FCE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ami's FDA import refusal history?
Ami (FEI: 3002082544) has 15 FDA import refusal record(s) in our database, spanning from 2/24/2002 to 10/31/2006.
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. Ami's FEI number is 3002082544.
What types of violations has Ami received?
Ami has been cited for 9 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 Ami come from?
All FDA import refusal data for Ami 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.