ALKALOID AD
⚠️ Moderate Risk
FEI: 1000529104 • Skopje, MK-NA • MACEDONIA
FEI Number
1000529104
Location
Skopje, MK-NA
Country
MACEDONIAAddress
Bulevard Aleksandar Makedonski 12, , Skopje, MK-NA, Macedonia
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
PRESRV LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.
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.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
SULFITELBL
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2007 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Detroit District Office (DET-DO) | |
| 5/2/2006 | 60SAB25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/2/2006 | 60PAA03MIDAZOLAM HYDROCHLORIDE (ANESTHESIA ADJUNCT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/4/2006 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/12/2002 | 23MGT01SESAME SEED PASTE (E.G., TAHINA), EDIBLE SEED PROD. | Detroit District Office (DET-DO) | |
| 8/12/2002 | 28BFT13CINNAMON, CASSIA, GROUND, CRACKED (SPICE) | Detroit District Office (DET-DO) | |
| 8/12/2002 | 28BFH09CARAWAY, GROUND, CRACKED (SPICE) | Detroit District Office (DET-DO) | |
| 8/12/2002 | 33GFT04FONDANT CANDY PIECES, SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE) | Detroit District Office (DET-DO) | |
| 8/12/2002 | 31KFT02TEA, GREEN | Detroit District Office (DET-DO) | |
| 7/2/2002 | 25EDH99MIXED VEGETABLES, N.E.C. | Detroit District Office (DET-DO) | |
| 7/2/2002 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Detroit District Office (DET-DO) | |
| 7/1/2002 | 38HDT28MIXED VEGETABLE SOUP, CREAMED, DRIED | Detroit District Office (DET-DO) | |
| 7/1/2002 | 24TFH21PARSLEY (LEAF & STEM VEGETABLE) | Detroit District Office (DET-DO) | |
| 7/1/2002 | 25SGH01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | Detroit District Office (DET-DO) | |
| 7/1/2002 | 38HFT19MUSHROOM SOUP, CREAMED, DRIED | Detroit District Office (DET-DO) | |
| 7/1/2002 | 36AFT99SUGAR PRODUCTS, N.E.C. | Detroit District Office (DET-DO) | |
| 7/1/2002 | 38FDT29VEGETABLE (SINGLE INGREDIENT NOT MENTIONED ELSEWHERE) SOUP, CREAMED | Detroit District Office (DET-DO) | |
| 7/1/2002 | 38HFT99CREAMED, DRIED SOUP, N.E.C. | Detroit District Office (DET-DO) | |
| 7/1/2002 | 38HFT19MUSHROOM SOUP, CREAMED, DRIED | Detroit District Office (DET-DO) | |
| 7/1/2002 | 38HFT19MUSHROOM SOUP, CREAMED, DRIED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is ALKALOID AD's FDA import refusal history?
ALKALOID AD (FEI: 1000529104) has 20 FDA import refusal record(s) in our database, spanning from 7/1/2002 to 6/14/2007.
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. ALKALOID AD's FEI number is 1000529104.
What types of violations has ALKALOID AD received?
ALKALOID AD has been cited for 14 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 ALKALOID AD come from?
All FDA import refusal data for ALKALOID AD 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.