B&J Supplies
⚠️ Moderate Risk
FEI: 3004168160 • Manchester • UNITED KINGDOM
FEI Number
3004168160
Location
Manchester
Country
UNITED KINGDOMAddress
June Almond House Mary St Strangway, , Manchester, , United Kingdom
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2012 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 4/20/2012 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Chicago District Office (CHI-DO) | |
| 4/20/2012 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Chicago District Office (CHI-DO) | |
| 4/20/2012 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Chicago District Office (CHI-DO) | |
| 9/14/2010 | 60SBY99ANTACID, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/14/2010 | 85HHLPAD, MENSTRUAL, SCENTED | Division of Southeast Imports (DSEI) | |
| 9/14/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/14/2010 | 61FBL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is B&J Supplies's FDA import refusal history?
B&J Supplies (FEI: 3004168160) has 8 FDA import refusal record(s) in our database, spanning from 9/14/2010 to 4/20/2012.
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. B&J Supplies's FEI number is 3004168160.
What types of violations has B&J Supplies received?
B&J Supplies has been cited for 5 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 B&J Supplies come from?
All FDA import refusal data for B&J Supplies 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.