BCM Ltd.
⚠️ High Risk
FEI: 3002806563 • Nottingham, NGM • UNITED KINGDOM
FEI Number
3002806563
Location
Nottingham, NGM
Country
UNITED KINGDOMAddress
1 Thane Road West, , Nottingham, NGM, United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2025 | 66PBL16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/8/2024 | 55QY16GLYCERIN (PHARMACEUTIC NECESSITY - HUMECTANT) | 335LACKS N/C | Division of Northeast Imports (DNEI) |
| 11/14/2022 | 62MAY99ANTI-PRURITIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2019 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2011 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | New Orleans District Office (NOL-DO) | |
| 1/13/2006 | 65NAA99RADIOACTIVE AGENT N.E.C. | New York District Office (NYK-DO) | |
| 7/18/2005 | 54AYL99VITAMIN, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BCM Ltd.'s FDA import refusal history?
BCM Ltd. (FEI: 3002806563) has 7 FDA import refusal record(s) in our database, spanning from 7/18/2005 to 8/22/2025.
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. BCM Ltd.'s FEI number is 3002806563.
What types of violations has BCM Ltd. received?
BCM Ltd. has been cited for 7 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 BCM Ltd. come from?
All FDA import refusal data for BCM 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.