Dr. Reddy's Laboratories Ltd, CTO Unit 1
⚠️ Moderate Risk
FEI: 3002806851 • Hyderabad, Telangana • INDIA
FEI Number
3002806851
Location
Hyderabad, Telangana
Country
INDIAAddress
No 137/138 & 145/146 Jinnaram Mandal, Sri Venkateswara Co-Operative Industrial Estate, Bollaram, Sangareddy, Hyderabad, Telangana, 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).
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 |
|---|---|---|---|
| 7/10/2020 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2017 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2017 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2010 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/8/2010 | 60LCA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/8/2010 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/8/2010 | 61PCA62PIOGLITAZONE HCL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/8/2010 | 62OCF41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/8/2010 | 66SCE27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/15/2008 | 62ICS80GEMCITABINE HCL (ANTI-NEOPLASTIC) | Chicago District Office (CHI-DO) | |
| 3/8/2006 | 62TDF02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Dr. Reddy's Laboratories Ltd, CTO Unit 1's FDA import refusal history?
Dr. Reddy's Laboratories Ltd, CTO Unit 1 (FEI: 3002806851) has 11 FDA import refusal record(s) in our database, spanning from 3/8/2006 to 7/10/2020.
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 Ltd, CTO Unit 1's FEI number is 3002806851.
What types of violations has Dr. Reddy's Laboratories Ltd, CTO Unit 1 received?
Dr. Reddy's Laboratories Ltd, CTO Unit 1 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's Laboratories Ltd, CTO Unit 1 come from?
All FDA import refusal data for Dr. Reddy's Laboratories Ltd, CTO Unit 1 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.