Ben Venue Laboratories Inc
⚠️ Moderate Risk
FEI: 1519257 • Bedford, OH • UNITED STATES
FEI Number
1519257
Location
Bedford, OH
Country
UNITED STATESAddress
300 Northfield Rd, , Bedford, OH, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2008 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/31/2007 | 60LCP09BUPRENORPHINE HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/31/2007 | 60SIY22FAMOTIDINE (ANTACID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/31/2007 | 60SIY22FAMOTIDINE (ANTACID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/31/2007 | 62OIY24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/12/2005 | 56YYY99ANTIBIOTIC N.E.C. | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Ben Venue Laboratories Inc's FDA import refusal history?
Ben Venue Laboratories Inc (FEI: 1519257) has 6 FDA import refusal record(s) in our database, spanning from 5/12/2005 to 5/9/2008.
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. Ben Venue Laboratories Inc's FEI number is 1519257.
What types of violations has Ben Venue Laboratories Inc received?
Ben Venue Laboratories Inc 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 Ben Venue Laboratories Inc come from?
All FDA import refusal data for Ben Venue Laboratories 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.