Natco Pharma Limited
⚠️ High Risk
FEI: 3001642990 • Banjara Hills, Andhra Pradesh • INDIA
FEI Number
3001642990
Location
Banjara Hills, Andhra Pradesh
Country
INDIAAddress
Kothur - 509 228., Natco House, Road No. 2, Banjara Hills, Andhra Pradesh, 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(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2021 | 56OCA02MOXIFLOXACIN HCL (FLUOROQUINOLONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2019 | 61CCE03REVLIMID | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/15/2018 | 62VDA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/24/2018 | 61CCB03REVLIMID | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 66YCH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2016 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/11/2016 | 62GDB99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2016 | 62VDE99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/7/2016 | 62VDA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/3/2016 | 62VDA99ANTI-VIRAL N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/10/2015 | 61EAY11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | New Orleans District Office (NOL-DO) | |
| 5/30/2013 | 64RCA17ANASTROZOLE (HORMONE) | 3741FRNMFGREG | Florida District Office (FLA-DO) |
| 9/9/2011 | 60LIS87RIZATRIPTAN BENZOATE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/17/2009 | 62VCA45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/29/2004 | 62ICE99ANTI-NEOPLASTIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Natco Pharma Limited's FDA import refusal history?
Natco Pharma Limited (FEI: 3001642990) has 18 FDA import refusal record(s) in our database, spanning from 1/29/2004 to 9/5/2023.
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. Natco Pharma Limited's FEI number is 3001642990.
What types of violations has Natco Pharma Limited received?
Natco Pharma Limited 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 Natco Pharma Limited come from?
All FDA import refusal data for Natco Pharma Limited 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.