Prime Meditech Corp.
⚠️ Moderate Risk
FEI: 3004617003 • Seoul • SOUTH KOREA
FEI Number
3004617003
Location
Seoul
Country
SOUTH KOREAAddress
3f Taeyeong Bldg., 291, Sangdo-Dong Dongjak-Gu, Seoul, , 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
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/8/2004 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | New York District Office (NYK-DO) | |
| 9/8/2004 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | New York District Office (NYK-DO) | |
| 9/8/2004 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | New York District Office (NYK-DO) | |
| 9/8/2004 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Prime Meditech Corp.'s FDA import refusal history?
Prime Meditech Corp. (FEI: 3004617003) has 4 FDA import refusal record(s) in our database, spanning from 9/8/2004 to 9/8/2004.
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. Prime Meditech Corp.'s FEI number is 3004617003.
What types of violations has Prime Meditech Corp. received?
Prime Meditech Corp. 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 Prime Meditech Corp. come from?
All FDA import refusal data for Prime Meditech Corp. 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.