Dr. Reddy's Laboratories Ltd., Generics
⚠️ Moderate Risk
FEI: 3003202659 • Bachupally, Telangana • INDIA
FEI Number
3003202659
Location
Bachupally, Telangana
Country
INDIAAddress
Integrated Product Dev. Org, Innovation Plaza, Bachupally, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2010 | 65PDR02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/17/2006 | 66VIB99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 7/1/2005 | 61EIS06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dr. Reddy's Laboratories Ltd., Generics's FDA import refusal history?
Dr. Reddy's Laboratories Ltd., Generics (FEI: 3003202659) has 3 FDA import refusal record(s) in our database, spanning from 7/1/2005 to 5/26/2010.
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., Generics's FEI number is 3003202659.
What types of violations has Dr. Reddy's Laboratories Ltd., Generics received?
Dr. Reddy's Laboratories Ltd., Generics 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., Generics come from?
All FDA import refusal data for Dr. Reddy's Laboratories Ltd., Generics 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.