Advanced Wound Recovery Boston L
✅ Low Risk
FEI: 3006026888 • Wellesley Hills, MA • UNITED STATES
FEI Number
3006026888
Location
Wellesley Hills, MA
Country
UNITED STATESAddress
65 Walnut St Ste 440, , Wellesley Hills, MA, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
Frequently Asked Questions
What is Advanced Wound Recovery Boston L's FDA import refusal history?
Advanced Wound Recovery Boston L (FEI: 3006026888) has 1 FDA import refusal record(s) in our database, spanning from 1/26/2007 to 1/26/2007.
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. Advanced Wound Recovery Boston L's FEI number is 3006026888.
What types of violations has Advanced Wound Recovery Boston L received?
Advanced Wound Recovery Boston L 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 Advanced Wound Recovery Boston L come from?
All FDA import refusal data for Advanced Wound Recovery Boston L 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.