PPB STUDIOS CO LTD
⚠️ High Risk
FEI: 3027782982 • Seongdong District, Seoul • SOUTH KOREA
FEI Number
3027782982
Location
Seongdong District, Seoul
Country
SOUTH KOREAAddress
Seongdong Gu, 04779 South Korea Tel 02 02; 6f Seongsuil Ro, Seongdong District, Seoul, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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 |
|---|---|---|---|
| 8/22/2024 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of West Coast Imports (DWCI) | |
| 1/5/2024 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Division of West Coast Imports (DWCI) | |
| 12/18/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Northern Border Imports (DNBI) | |
| 12/5/2023 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Northern Border Imports (DNBI) | |
| 11/29/2023 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Division of Northern Border Imports (DNBI) | |
| 11/28/2023 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Division of Northern Border Imports (DNBI) | |
| 11/27/2023 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Division of West Coast Imports (DWCI) | |
| 11/22/2023 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of West Coast Imports (DWCI) | |
| 11/22/2023 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of West Coast Imports (DWCI) | |
| 11/21/2023 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Northern Border Imports (DNBI) | |
| 11/21/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 11/21/2023 | 86NCZLENS, CONTACT, FOR COLOR VISION DEFICIENCY | Division of West Coast Imports (DWCI) | |
| 11/17/2023 | 86LOHSYSTEM, IDENTIFICATION, CONTACT LENS | Division of Northern Border Imports (DNBI) | |
| 11/16/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Northern Border Imports (DNBI) | |
| 11/15/2023 | 86LOHSYSTEM, IDENTIFICATION, CONTACT LENS | Division of West Coast Imports (DWCI) | |
| 11/7/2023 | 86LOHSYSTEM, IDENTIFICATION, CONTACT LENS | Division of Northern Border Imports (DNBI) | |
| 11/7/2023 | 86LOHSYSTEM, IDENTIFICATION, CONTACT LENS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is PPB STUDIOS CO LTD's FDA import refusal history?
PPB STUDIOS CO LTD (FEI: 3027782982) has 17 FDA import refusal record(s) in our database, spanning from 11/7/2023 to 8/22/2024.
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. PPB STUDIOS CO LTD's FEI number is 3027782982.
What types of violations has PPB STUDIOS CO LTD received?
PPB STUDIOS 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 PPB STUDIOS CO LTD come from?
All FDA import refusal data for PPB STUDIOS 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.