Dr. Reddy's Laboratories Limited CTO VI
⚠️ Moderate Risk
FEI: 3002949085 • Srikakulam, Andhra Pradesh • INDIA
FEI Number
3002949085
Location
Srikakulam, Andhra Pradesh
Country
INDIAAddress
APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/25/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/14/2013 | 66YCT99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 5/18/2005 | 62GCS49NAPROXEN (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/22/2004 | 62GAS50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dr. Reddy's Laboratories Limited CTO VI's FDA import refusal history?
Dr. Reddy's Laboratories Limited CTO VI (FEI: 3002949085) has 4 FDA import refusal record(s) in our database, spanning from 10/22/2004 to 8/25/2020.
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 CTO VI's FEI number is 3002949085.
What types of violations has Dr. Reddy's Laboratories Limited CTO VI received?
Dr. Reddy's Laboratories Limited CTO VI 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 Limited CTO VI come from?
All FDA import refusal data for Dr. Reddy's Laboratories Limited CTO VI 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.