Meta Biomed Co., LTD.
⚠️ Moderate Risk
FEI: 3005907356 • Cheongju, Chungcheongbuk • SOUTH KOREA
FEI Number
3005907356
Location
Cheongju, Chungcheongbuk
Country
SOUTH KOREAAddress
Osong-Eup, Heungdeok, 270 Osongsaengmyeong1-Ro; Heungdeok, Cheongju, Chungcheongbuk, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2018 | 79GANSUTURE, ABSORBABLE, SYNTHETIC | Division of Southeast Imports (DSEI) | |
| 10/5/2017 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 8/5/2016 | 76EKRPLUGGER, ROOT CANAL, ENDODONTIC | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 6/25/2014 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76KIFRESIN, ROOT CANAL FILLING | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76KIFRESIN, ROOT CANAL FILLING | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76KIFRESIN, ROOT CANAL FILLING | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EKMGUTTA-PERCHA | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/25/2014 | 76EKMGUTTA-PERCHA | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/26/2014 | 76EKMGUTTA-PERCHA | 341REGISTERED | San Juan District Office (SJN-DO) |
| 1/4/2011 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Meta Biomed Co., LTD.'s FDA import refusal history?
Meta Biomed Co., LTD. (FEI: 3005907356) has 19 FDA import refusal record(s) in our database, spanning from 1/4/2011 to 4/5/2018.
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. Meta Biomed Co., LTD.'s FEI number is 3005907356.
What types of violations has Meta Biomed Co., LTD. received?
Meta Biomed Co., LTD. 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 Meta Biomed Co., LTD. come from?
All FDA import refusal data for Meta Biomed Co., 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.