FMC Corporation - Peroxygen Chemicals Division
⚠️ Moderate Risk
FEI: 3002704390 • Philadelphia, PA • UNITED STATES
FEI Number
3002704390
Location
Philadelphia, PA
Country
UNITED STATESAddress
2929 Walnut St, , Philadelphia, PA, United States
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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/20/2020 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2280DIRSEXMPT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FMC Corporation - Peroxygen Chemicals Division's FDA import refusal history?
FMC Corporation - Peroxygen Chemicals Division (FEI: 3002704390) has 1 FDA import refusal record(s) in our database, spanning from 2/20/2020 to 2/20/2020.
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. FMC Corporation - Peroxygen Chemicals Division's FEI number is 3002704390.
What types of violations has FMC Corporation - Peroxygen Chemicals Division received?
FMC Corporation - Peroxygen Chemicals Division has been cited for 1 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 FMC Corporation - Peroxygen Chemicals Division come from?
All FDA import refusal data for FMC Corporation - Peroxygen Chemicals Division 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.