Sumitomo Pharma America, Inc.
⚠️ Moderate Risk
FEI: 1222021 • Marlborough, MA • UNITED STATES
FEI Number
1222021
Location
Marlborough, MA
Country
UNITED STATESAddress
84 Waterford Dr, , Marlborough, MA, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 3/22/2023 | 63BDK27LEVALBUTEROL HCL (BRONCHODILATOR) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 6/15/2020 | 63BCY27LEVALBUTEROL HCL (BRONCHODILATOR) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/11/2012 | 63BCQ27LEVALBUTEROL HCL (BRONCHODILATOR) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sumitomo Pharma America, Inc.'s FDA import refusal history?
Sumitomo Pharma America, Inc. (FEI: 1222021) has 3 FDA import refusal record(s) in our database, spanning from 9/11/2012 to 3/22/2023.
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. Sumitomo Pharma America, Inc.'s FEI number is 1222021.
What types of violations has Sumitomo Pharma America, Inc. received?
Sumitomo Pharma America, Inc. 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 Sumitomo Pharma America, Inc. come from?
All FDA import refusal data for Sumitomo Pharma America, Inc. 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.