Dr. Reddy's Laboratories Limited
⚠️ Moderate Risk
FEI: 3004464238 • AP, Andhra Pradesh • INDIA
FEI Number
3004464238
Location
AP, Andhra Pradesh
Country
INDIAAddress
7-1-27, Ameerpet, , Hyderabad, AP, Andhra Pradesh, India
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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/1/2018 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2017 | 62VDA12RIBAVIRIN (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 64UDA99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2012 | 61PCA62PIOGLITAZONE HCL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2012 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/22/2010 | 64UCA99INHIBITOR N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/28/2008 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/3/2008 | 63XCP51IOGLICIC ACID (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/13/2007 | 62KCE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/18/2007 | 62OBB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 1/31/2006 | 63VAJ99DEPIGMENTOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/28/2005 | 63ADB02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/10/2005 | 63XDY99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/19/2005 | 63EDB99CARDIAC DEPRESSANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/28/2005 | 63XDA99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Dr. Reddy's Laboratories Limited's FDA import refusal history?
Dr. Reddy's Laboratories Limited (FEI: 3004464238) has 15 FDA import refusal record(s) in our database, spanning from 4/28/2005 to 10/1/2018.
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's Laboratories Limited's FEI number is 3004464238.
What types of violations has Dr. Reddy's Laboratories Limited received?
Dr. Reddy's Laboratories Limited has been cited for 4 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's Laboratories Limited come from?
All FDA import refusal data for Dr. Reddy's Laboratories Limited 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.