Accord-UK Ltd.
⚠️ High Risk
FEI: 3006750335 • Barnstaple, Devon • UNITED KINGDOM
FEI Number
3006750335
Location
Barnstaple, Devon
Country
UNITED KINGDOMAddress
Whiddon Valley, , Barnstaple, Devon, 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
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 |
|---|---|---|---|
| 6/28/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 64BDA07BENDROFLUMETHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2021 | 56ECY20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/29/2021 | 56EDY20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 61JCH09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 60LCP01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 64BDA07BENDROFLUMETHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/1/2017 | 60LDA99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/2/2017 | 62JDY13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2016 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2014 | 63FCH06DIGOXIN (CARDIOTONIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2012 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/19/2005 | 63ECB13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Accord-UK Ltd.'s FDA import refusal history?
Accord-UK Ltd. (FEI: 3006750335) has 13 FDA import refusal record(s) in our database, spanning from 10/19/2005 to 6/28/2023.
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. Accord-UK Ltd.'s FEI number is 3006750335.
What types of violations has Accord-UK Ltd. received?
Accord-UK Ltd. has been cited for 2 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 Accord-UK Ltd. come from?
All FDA import refusal data for Accord-UK 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.