DR REDDY LABORATORIES UK
⚠️ Moderate Risk
FEI: 3012283694 • Beverley • UNITED KINGDOM
FEI Number
3012283694
Location
Beverley
Country
UNITED KINGDOMAddress
6 Riverview Road, , Beverley, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2019 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/20/2019 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2016 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/11/2016 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/11/2010 | 62KDC10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | New York District Office (NYK-DO) | |
| 10/6/2009 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/3/2008 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is DR REDDY LABORATORIES UK's FDA import refusal history?
DR REDDY LABORATORIES UK (FEI: 3012283694) has 7 FDA import refusal record(s) in our database, spanning from 11/3/2008 to 12/11/2019.
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. DR REDDY LABORATORIES UK's FEI number is 3012283694.
What types of violations has DR REDDY LABORATORIES UK received?
DR REDDY LABORATORIES UK 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 DR REDDY LABORATORIES UK come from?
All FDA import refusal data for DR REDDY LABORATORIES UK 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.