Plum A/S
⚠️ High Risk
FEI: 3005147993 • Assens • DENMARK
FEI Number
3005147993
Location
Assens
Country
DENMARKAddress
Frederik Plums Vej 2, , Assens, , Denmark
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 5/29/2015 | 65FBK06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 5/29/2015 | 65FBK06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 5/29/2015 | 65FBK06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 5/29/2015 | 65FBK06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 5/29/2015 | 65FBK06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 5/29/2015 | 65FBK06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 5/29/2015 | 65FBK06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Plum A/S's FDA import refusal history?
Plum A/S (FEI: 3005147993) has 7 FDA import refusal record(s) in our database, spanning from 5/29/2015 to 5/29/2015.
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. Plum A/S's FEI number is 3005147993.
What types of violations has Plum A/S received?
Plum A/S 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 Plum A/S come from?
All FDA import refusal data for Plum A/S 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.