Koperasi Pamane Agro Makmur
⚠️ Moderate Risk
FEI: 3011881442 • Pontianak, Kalimantan Barat • INDONESIA
FEI Number
3011881442
Location
Pontianak, Kalimantan Barat
Country
INDONESIAAddress
Hulu, Kec. Pontianak Timur, Jl. Bintangor Dalam, No.109, Kel Tanjung, Pontianak, Kalimantan 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.
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).
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/24/2016 | 54JYR12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | New Orleans District Office (NOL-DO) |
| 4/7/2016 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | San Francisco District Office (SAN-DO) |
| 4/6/2016 | 54KCS12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | San Francisco District Office (SAN-DO) | |
| 4/6/2016 | 54KCS12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | San Francisco District Office (SAN-DO) | |
| 4/6/2016 | 54FYY99HERBALS & 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) |
| 2/17/2016 | 66BCS99STIMULANT N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/17/2016 | 66BCS99STIMULANT N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/17/2016 | 66BCS99STIMULANT N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/2/2016 | 66BCS99STIMULANT N.E.C. | 2120UNSFDIETSP | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Koperasi Pamane Agro Makmur's FDA import refusal history?
Koperasi Pamane Agro Makmur (FEI: 3011881442) has 10 FDA import refusal record(s) in our database, spanning from 2/2/2016 to 8/24/2016.
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. Koperasi Pamane Agro Makmur's FEI number is 3011881442.
What types of violations has Koperasi Pamane Agro Makmur received?
Koperasi Pamane Agro Makmur 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 Koperasi Pamane Agro Makmur come from?
All FDA import refusal data for Koperasi Pamane Agro Makmur 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.