Gufic Biosciences Limited
⚠️ High Risk
FEI: 3003200255 • Navsari, Gujarat • INDIA
FEI Number
3003200255
Location
Navsari, Gujarat
Country
INDIAAddress
National Highway No. 8, Near Grid, Navsari, Gujarat, 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
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.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2026 | 58JCP04CHORIONIC GONADOTROPIN | Division of Southeast Imports (DSEI) | |
| 5/17/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 54YFK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/28/2013 | 60QIS40LIDOCAINE HCL (ANESTHETIC) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 12/16/2011 | 60QAS40LIDOCAINE HCL (ANESTHETIC) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 8/15/2007 | 61WIY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/15/2007 | 60QIY07LIDOCAINE | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/12/2006 | 61WBR18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 5/18/2005 | 61WAY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Gufic Biosciences Limited's FDA import refusal history?
Gufic Biosciences Limited (FEI: 3003200255) has 9 FDA import refusal record(s) in our database, spanning from 5/18/2005 to 1/7/2026.
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. Gufic Biosciences Limited's FEI number is 3003200255.
What types of violations has Gufic Biosciences Limited received?
Gufic Biosciences Limited has been cited for 4 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 Gufic Biosciences Limited come from?
All FDA import refusal data for Gufic Biosciences 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.