J.B. Chemicals & Pharmaceuticals Ltd.
⚠️ High Risk
FEI: 3004087070 • Ankleshwar, Gujarat • INDIA
FEI Number
3004087070
Location
Ankleshwar, Gujarat
Country
INDIAAddress
128/1 Gidc Naka, , Ankleshwar, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/26/2025 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 8/13/2025 | 66SDY27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/16/2025 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is J.B. Chemicals & Pharmaceuticals Ltd.'s FDA import refusal history?
J.B. Chemicals & Pharmaceuticals Ltd. (FEI: 3004087070) has 3 FDA import refusal record(s) in our database, spanning from 5/16/2025 to 8/26/2025.
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. J.B. Chemicals & Pharmaceuticals Ltd.'s FEI number is 3004087070.
What types of violations has J.B. Chemicals & Pharmaceuticals Ltd. received?
J.B. Chemicals & Pharmaceuticals Ltd. 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 J.B. Chemicals & Pharmaceuticals Ltd. come from?
All FDA import refusal data for J.B. Chemicals & Pharmaceuticals 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.