PMA TRADE
⚠️ High Risk
FEI: 3025994428 • Tangerang • INDONESIA
FEI Number
3025994428
Location
Tangerang
Country
INDONESIAAddress
Ji Kenanga 1 No 2, , Tangerang, , Indonesia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/11/2023 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 4/25/2023 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 4/25/2023 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 4/25/2023 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 4/5/2023 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 3/16/2023 | 54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 3/1/2023 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2023 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2023 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2023 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/16/2023 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PMA TRADE's FDA import refusal history?
PMA TRADE (FEI: 3025994428) has 11 FDA import refusal record(s) in our database, spanning from 2/16/2023 to 5/11/2023.
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. PMA TRADE's FEI number is 3025994428.
What types of violations has PMA TRADE received?
PMA TRADE has been cited for 3 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 PMA TRADE come from?
All FDA import refusal data for PMA TRADE 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.