Bell, Sons & Co. (Druggists) Ltd.
⚠️ Moderate Risk
FEI: 3007190720 • Southport, Merseyside • UNITED KINGDOM
FEI Number
3007190720
Location
Southport, Merseyside
Country
UNITED KINGDOMAddress
Gifford House, Slaidburn Crescent, Southport, Merseyside, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2024 | 60BDL01AMMONIUM CHLORIDE (ACIDIFIER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2017 | 66YAL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 223FALSE | Division of Northeast Imports (DNEI) |
| 5/6/2016 | 60LBY99ANALGESIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/9/2011 | 56GBJ99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
| 3/23/2005 | 55PY02OLIVE OIL (PHARMACEUTIC NECESSITY) | New York District Office (NYK-DO) | |
| 10/7/2002 | 62QBJ99ANTI-RHEUMATIC N.E.C. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Bell, Sons & Co. (Druggists) Ltd.'s FDA import refusal history?
Bell, Sons & Co. (Druggists) Ltd. (FEI: 3007190720) has 7 FDA import refusal record(s) in our database, spanning from 10/7/2002 to 12/15/2024.
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. Bell, Sons & Co. (Druggists) Ltd.'s FEI number is 3007190720.
What types of violations has Bell, Sons & Co. (Druggists) Ltd. received?
Bell, Sons & Co. (Druggists) Ltd. has been cited for 6 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 Bell, Sons & Co. (Druggists) Ltd. come from?
All FDA import refusal data for Bell, Sons & Co. (Druggists) Ltd. 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.