Synthimed Labs Private Limited
⚠️ High Risk
FEI: 3005895238 • Mohali, Punjab • INDIA
FEI Number
3005895238
Location
Mohali, Punjab
Country
INDIAAddress
Barwala Road, Bhagwanpur Village, Derabassi District, Mohali, Punjab, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2025 | 64LCA03BETAMETHASONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 10/6/2014 | 62LCZ99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/26/2014 | 61FCS56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/18/2013 | 61JCS08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | New Orleans District Office (NOL-DO) | |
| 5/17/2012 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Synthimed Labs Private Limited's FDA import refusal history?
Synthimed Labs Private Limited (FEI: 3005895238) has 5 FDA import refusal record(s) in our database, spanning from 5/17/2012 to 9/29/2025.
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. Synthimed Labs Private Limited's FEI number is 3005895238.
What types of violations has Synthimed Labs Private Limited received?
Synthimed Labs Private 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 Synthimed Labs Private Limited come from?
All FDA import refusal data for Synthimed Labs Private 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.