Dr. Reddy's Laboratories Limited (Unit II)
⚠️ Moderate Risk
FEI: 3005448030 • Hyderabad, Telangana • INDIA
FEI Number
3005448030
Location
Hyderabad, Telangana
Country
INDIAAddress
Plot No 1, 75a,75b,105,110, 111&112, Sri Venkateswara Co-Operative Industrial Estate, Bollaram, Jinnaram Mandal, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2020 | 64DAO99EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 66MAA76CHLORDIAZEPOXIDE (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 61XAO49AZELASTINE, ANTI-HISTAMINE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 61TCH31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2016 | 66VCH99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 6/18/2012 | 66TIE01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/30/2010 | 80KYZSYRINGE, IRRIGATING | 341REGISTERED | New York District Office (NYK-DO) |
| 9/26/2004 | 62GAA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/26/2004 | 62GAA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/26/2004 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/26/2004 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/2/2002 | 61HIY99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Dr. Reddy's Laboratories Limited (Unit II)'s FDA import refusal history?
Dr. Reddy's Laboratories Limited (Unit II) (FEI: 3005448030) has 14 FDA import refusal record(s) in our database, spanning from 11/2/2002 to 12/29/2020.
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 Limited (Unit II)'s FEI number is 3005448030.
What types of violations has Dr. Reddy's Laboratories Limited (Unit II) received?
Dr. Reddy's Laboratories Limited (Unit II) 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 Limited (Unit II) come from?
All FDA import refusal data for Dr. Reddy's Laboratories Limited (Unit II) 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.