Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)
⚠️ High Risk
FEI: 3003647459 • Daman, Dadra and Nagar Haveli and Dam • INDIA
FEI Number
3003647459
Location
Daman, Dadra and Nagar Haveli and Dam
Country
INDIAAddress
Survey No.101/2 & 102/1, Daman Industrial Estate, Airport Road, , Kadaiya, Daman, Dadra and Nagar Haveli and Dam, 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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/13/2025 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/9/2025 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/20/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/14/2025 | 62CCB99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/30/2018 | 60SCA28RANITIDINE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2013 | 61CDR01LEUCOVORIN CALCIUM (ANTI-ANEMIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/30/2013 | 61CDR01LEUCOVORIN CALCIUM (ANTI-ANEMIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/9/2011 | 61LBK14CHLORHEXIDINE GLUCONATE | 473LABELING | New York District Office (NYK-DO) |
| 10/30/2009 | 62LDJ40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)'s FDA import refusal history?
Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd) (FEI: 3003647459) has 11 FDA import refusal record(s) in our database, spanning from 10/30/2009 to 11/13/2025.
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. Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)'s FEI number is 3003647459.
What types of violations has Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd) received?
Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd) has been cited for 6 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 Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd) come from?
All FDA import refusal data for Unique Pharmaceutical Laboratories (A Div. of JB 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.