Pharmahemp D.O.O.
⚠️ Moderate Risk
FEI: 3012045831 • Ljubljana, Osrednjeslovenska • SLOVENIA
FEI Number
3012045831
Location
Ljubljana, Osrednjeslovenska
Country
SLOVENIAAddress
Koprska ulica 106c, , Ljubljana, Osrednjeslovenska, Slovenia
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
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.
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).
NCONTACT
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(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/23/2018 | 54YEY15HEMP PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 1/29/2018 | 66VLY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/28/2016 | 54YYL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Pharmahemp D.O.O.'s FDA import refusal history?
Pharmahemp D.O.O. (FEI: 3012045831) has 3 FDA import refusal record(s) in our database, spanning from 12/28/2016 to 8/23/2018.
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. Pharmahemp D.O.O.'s FEI number is 3012045831.
What types of violations has Pharmahemp D.O.O. received?
Pharmahemp D.O.O. has been cited for 8 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 Pharmahemp D.O.O. come from?
All FDA import refusal data for Pharmahemp D.O.O. 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.