PNP Biopharm Co., Ltd.
⚠️ Moderate Risk
FEI: 3012867987 • Seoul, Seoul • SOUTH KOREA
FEI Number
3012867987
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
33 11, Digital-ro, Gil, Guro-gu, Seoul, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2016 | 65LBJ99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/20/2016 | 65LBJ99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/20/2016 | 65LBJ99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/20/2016 | 65LAJ99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is PNP Biopharm Co., Ltd.'s FDA import refusal history?
PNP Biopharm Co., Ltd. (FEI: 3012867987) has 4 FDA import refusal record(s) in our database, spanning from 12/20/2016 to 12/20/2016.
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. PNP Biopharm Co., Ltd.'s FEI number is 3012867987.
What types of violations has PNP Biopharm Co., Ltd. received?
PNP Biopharm Co., Ltd. has been cited for 2 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 PNP Biopharm Co., Ltd. come from?
All FDA import refusal data for PNP Biopharm 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.