Bolenny and CO Global Services Limited
⚠️ Moderate Risk
FEI: 3016817847 • Ibadan, OYO • NIGERIA
FEI Number
3016817847
Location
Ibadan, OYO
Country
NIGERIAAddress
Plot 6, Zone 13, Phase 1, Abraham Oronyon Street, Buso. Rock Hotel, Kukumoda, New Iife Rd, , Ibadan, OYO, Nigeria
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
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).
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.
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).
Refusal History
Frequently Asked Questions
What is Bolenny and CO Global Services Limited's FDA import refusal history?
Bolenny and CO Global Services Limited (FEI: 3016817847) has 3 FDA import refusal record(s) in our database, spanning from 2/11/2021 to 2/11/2021.
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. Bolenny and CO Global Services Limited's FEI number is 3016817847.
What types of violations has Bolenny and CO Global Services Limited received?
Bolenny and CO Global Services Limited has been cited for 4 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 Bolenny and CO Global Services Limited come from?
All FDA import refusal data for Bolenny and CO Global Services Limited 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.