CV BAGUS PERDANA
⚠️ Moderate Risk
FEI: 3013168440 • Gresik, Jawa Timur • INDONESIA
FEI Number
3013168440
Location
Gresik, Jawa Timur
Country
INDONESIAAddress
Jln. Kapten Dulasim 3, , Gresik, Jawa Timur, 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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
DIETARYING
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2018 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/18/2017 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southwest Imports (DSWI) |
| 12/13/2017 | 53DH99OTHER FRAGRANCE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CV BAGUS PERDANA's FDA import refusal history?
CV BAGUS PERDANA (FEI: 3013168440) has 3 FDA import refusal record(s) in our database, spanning from 12/13/2017 to 1/12/2018.
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. CV BAGUS PERDANA's FEI number is 3013168440.
What types of violations has CV BAGUS PERDANA received?
CV BAGUS PERDANA 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 CV BAGUS PERDANA come from?
All FDA import refusal data for CV BAGUS PERDANA 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.