Arsy CV
⚠️ Moderate Risk
FEI: 3011765542 • Bekasi, Jabotabek • INDONESIA
FEI Number
3011765542
Location
Bekasi, Jabotabek
Country
INDONESIAAddress
Jatiwaringin, , Bekasi, Jabotabek, Indonesia
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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
STD 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(g)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided under Section 401 of the FD&C Act and the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation.
UNSAFE SUB
The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/13/2020 | 54KY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 6/23/2017 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 4/19/2017 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 4/19/2017 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 4/19/2017 | 54JBR12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 238UNSAFE ADD | Division of Southeast Imports (DSEI) |
| 4/19/2017 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 3/30/2017 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 10/4/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 8/1/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 2/17/2016 | 66BCS99STIMULANT N.E.C. | Division of West Coast Imports (DWCI) | |
| 1/4/2016 | 54FYY95BANABA (HERBAL & BOTANICALS, NOT TEAS) | 280UNSAFE SUB | Los Angeles District Office (LOS-DO) |
| 1/4/2016 | 54Y99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 280UNSAFE SUB | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Arsy CV's FDA import refusal history?
Arsy CV (FEI: 3011765542) has 12 FDA import refusal record(s) in our database, spanning from 1/4/2016 to 7/13/2020.
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. Arsy CV's FEI number is 3011765542.
What types of violations has Arsy CV received?
Arsy CV has been cited for 10 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 Arsy CV come from?
All FDA import refusal data for Arsy CV 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.