Wijaya Cv
⚠️ Moderate Risk
FEI: 3012070245 • Barat • INDONESIA
FEI Number
3012070245
Location
Barat
Country
INDONESIAAddress
Jl Andini Sakti No 51, , Barat, , 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.
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2016 | 54KBY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 238UNSAFE ADD | Division of Southeast Imports (DSEI) |
| 4/6/2016 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | San Francisco District Office (SAN-DO) |
| 3/28/2016 | 54KBT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | San Francisco District Office (SAN-DO) |
| 3/28/2016 | 54JCS12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | San Francisco District Office (SAN-DO) |
| 3/28/2016 | 54JCS12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | San Francisco District Office (SAN-DO) |
| 3/28/2016 | 54JCS12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | San Francisco District Office (SAN-DO) |
| 3/24/2016 | 54KBT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Wijaya Cv's FDA import refusal history?
Wijaya Cv (FEI: 3012070245) has 7 FDA import refusal record(s) in our database, spanning from 3/24/2016 to 11/18/2016.
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. Wijaya Cv's FEI number is 3012070245.
What types of violations has Wijaya Cv received?
Wijaya Cv 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 Wijaya Cv come from?
All FDA import refusal data for Wijaya 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.