Jermuk
⚠️ Moderate Risk
FEI: 3004287962 • Jermuk, Vayots Dzor • ARMENIA
FEI Number
3004287962
Location
Jermuk, Vayots Dzor
Country
ARMENIAAddress
1 Gortaranain Str., , Jermuk, Vayots Dzor, Armenia
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
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/13/2019 | 29WCT02BOTTLED SPRING OR MINERAL WATER | 251POISONOUS | Division of West Coast Imports (DWCI) |
| 2/21/2019 | 29WCT02BOTTLED SPRING OR MINERAL WATER | 251POISONOUS | Division of West Coast Imports (DWCI) |
| 10/1/2010 | 29WCT02BOTTLED SPRING OR MINERAL WATER | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 8/13/2009 | 29WCE02BOTTLED SPRING OR MINERAL WATER | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 10/24/2008 | 29WCE02BOTTLED SPRING OR MINERAL WATER | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 10/24/2008 | 29WCE02BOTTLED SPRING OR MINERAL WATER | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 1/21/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/15/2004 | 29WCT02BOTTLED SPRING OR MINERAL WATER | 260FALSE | Los Angeles District Office (LOS-DO) |
| 4/27/2004 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Jermuk's FDA import refusal history?
Jermuk (FEI: 3004287962) has 9 FDA import refusal record(s) in our database, spanning from 4/27/2004 to 3/13/2019.
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. Jermuk's FEI number is 3004287962.
What types of violations has Jermuk received?
Jermuk 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 Jermuk come from?
All FDA import refusal data for Jermuk 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.