Dr. Reddy's Laboratories Ltd.
⚠️ High Risk
FEI: 3002949099 • Medchal-Malkajgiri District, Telangana • INDIA
FEI Number
3002949099
Location
Medchal-Malkajgiri District, Telangana
Country
INDIAAddress
Survey No. 41, 42 part, 45 part & 46 part,Bachupally Village and Mandal, , Medchal-Malkajgiri District, Telangana, India
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2025 | 61XCY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 64HDK02GUAIFENESIN (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2024 | 66VDE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2023 | 65GDJ99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/1/2023 | 61MCY42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2019 | 60QDA07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2019 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 11/24/2017 | 66MCA83HYDROXYZINE HCL (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/22/2016 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 6/22/2016 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 3/16/2016 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2014 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/5/2014 | 64BCB48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/5/2014 | 62ODB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/21/2012 | 66SCA51TADALAFIL | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/25/2006 | 65QCA65TIZANIDINE HCL (RELAXANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dr. Reddy's Laboratories Ltd.'s FDA import refusal history?
Dr. Reddy's Laboratories Ltd. (FEI: 3002949099) has 18 FDA import refusal record(s) in our database, spanning from 7/25/2006 to 3/4/2025.
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. Dr. Reddy's Laboratories Ltd.'s FEI number is 3002949099.
What types of violations has Dr. Reddy's Laboratories Ltd. received?
Dr. Reddy's Laboratories Ltd. has been cited for 3 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. come from?
All FDA import refusal data for Dr. Reddy's Laboratories 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.