FillTech USA, LLC
⚠️ High Risk
FEI: 1000512200 • Rockwell, NC • UNITED STATES
FEI Number
1000512200
Location
Rockwell, NC
Country
UNITED STATESAddress
380 Palmer Rd, , Rockwell, NC, United States
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
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 |
|---|---|---|---|
| 6/9/2016 | 62MBJ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/9/2016 | 61HBY17PARACHLOROPHENOL (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/9/2016 | 55QY45PHENOL (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/9/2016 | 62MBY01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/9/2016 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/9/2016 | 62MBJ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is FillTech USA, LLC's FDA import refusal history?
FillTech USA, LLC (FEI: 1000512200) has 6 FDA import refusal record(s) in our database, spanning from 6/9/2016 to 6/9/2016.
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. FillTech USA, LLC's FEI number is 1000512200.
What types of violations has FillTech USA, LLC received?
FillTech USA, LLC 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 FillTech USA, LLC come from?
All FDA import refusal data for FillTech USA, LLC 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.