Greenwood Importers Llc
⚠️ Moderate Risk
FEI: 3010055012 • Baltimore, MD • UNITED STATES
FEI Number
3010055012
Location
Baltimore, MD
Country
UNITED STATESAddress
2709 N Rolling Rd Ste 116, , Baltimore, MD, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
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 |
|---|---|---|---|
| 5/29/2019 | 76EJLBUR, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 76EKQPREPARER, ROOT CANAL ENDODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 76EGZHOLDER, FILM, X-RAY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 76KXRAPPLICATOR, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 76EIEDAM, RUBBER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 60QCJ56BENZOCAINE (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 5/29/2019 | 76EMACEMENT, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Greenwood Importers Llc's FDA import refusal history?
Greenwood Importers Llc (FEI: 3010055012) has 10 FDA import refusal record(s) in our database, spanning from 5/29/2019 to 5/29/2019.
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. Greenwood Importers Llc's FEI number is 3010055012.
What types of violations has Greenwood Importers Llc received?
Greenwood Importers Llc has been cited for 3 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 Greenwood Importers Llc come from?
All FDA import refusal data for Greenwood Importers 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.