HAB Pharmaceuticals and Research, Ltd.
⚠️ Moderate Risk
FEI: 3004518474 • Vasai, Maharashtra • INDIA
FEI Number
3004518474
Location
Vasai, Maharashtra
Country
INDIAAddress
18/1 D & S Ind Complex, , Vasai, Maharashtra, 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).
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 |
|---|---|---|---|
| 3/12/2022 | 60MCA99ANALGESIC, NARCOTIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2022 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2019 | 62LCC37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Southwest Imports (DSWI) | |
| 7/1/2014 | 61NCA74MODAFINIL (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/12/2012 | 61NCA74MODAFINIL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/2/2005 | 62VIY18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is HAB Pharmaceuticals and Research, Ltd.'s FDA import refusal history?
HAB Pharmaceuticals and Research, Ltd. (FEI: 3004518474) has 7 FDA import refusal record(s) in our database, spanning from 2/2/2005 to 3/12/2022.
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. HAB Pharmaceuticals and Research, Ltd.'s FEI number is 3004518474.
What types of violations has HAB Pharmaceuticals and Research, Ltd. received?
HAB Pharmaceuticals and Research, 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 HAB Pharmaceuticals and Research, Ltd. come from?
All FDA import refusal data for HAB Pharmaceuticals and Research, 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.