Geranti Pharm Ltd.
⚠️ Moderate Risk
FEI: 3003529686 • Korea • SOUTH KOREA
FEI Number
3003529686
Location
Korea
Country
SOUTH KOREAAddress
678-2, , Seoul, Korea, , South Korea
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.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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).
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/23/2003 | 54YDY09GERMANIUM (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Los Angeles District Office (LOS-DO) | |
| 4/23/2003 | 54YDY09GERMANIUM (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Los Angeles District Office (LOS-DO) | |
| 4/23/2003 | 54YDY09GERMANIUM (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Los Angeles District Office (LOS-DO) | |
| 4/23/2003 | 54YDY09GERMANIUM (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Los Angeles District Office (LOS-DO) | |
| 4/23/2003 | 54YDY09GERMANIUM (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Geranti Pharm Ltd.'s FDA import refusal history?
Geranti Pharm Ltd. (FEI: 3003529686) has 5 FDA import refusal record(s) in our database, spanning from 4/23/2003 to 4/23/2003.
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. Geranti Pharm Ltd.'s FEI number is 3003529686.
What types of violations has Geranti Pharm Ltd. received?
Geranti Pharm Ltd. 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 Geranti Pharm Ltd. come from?
All FDA import refusal data for Geranti Pharm Ltd. 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.