Vapotherm, Inc.
⚠️ Moderate Risk
FEI: 3023209222 • Tijuana, Baja California • MEXICO
FEI Number
3023209222
Location
Tijuana, Baja California
Country
MEXICOAddress
Calle Guerrero Negro 9965, Colonia Parque Industrial Pacifico Cuarta Etapa, Tijuana, Baja California, Mexico
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2025 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 2/24/2025 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 2/24/2025 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 2/24/2025 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 2/24/2025 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Vapotherm, Inc.'s FDA import refusal history?
Vapotherm, Inc. (FEI: 3023209222) has 5 FDA import refusal record(s) in our database, spanning from 2/24/2025 to 2/24/2025.
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. Vapotherm, Inc.'s FEI number is 3023209222.
What types of violations has Vapotherm, Inc. received?
Vapotherm, 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 Vapotherm, Inc. come from?
All FDA import refusal data for Vapotherm, 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.