Ramlal Laboratories/Pvt/Ltd
⚠️ High Risk
FEI: 3004449031 • Oalcutta • 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2004 | 61HAA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 61XAA09CINNARIZINE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 66MAA03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 61FAA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 60WAA01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 66SAA05FLUNARIZINE HCL (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 60WAA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 60SAA22FAMOTIDINE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 61FAA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 61XAA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 62LAA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 61XAA21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 61FAA24CLOXYQUIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ramlal Laboratories/Pvt/Ltd's FDA import refusal history?
Ramlal Laboratories/Pvt/Ltd (FEI: 3004449031) has 19 FDA import refusal record(s) in our database, spanning from 3/10/2004 to 3/10/2004.
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. Ramlal Laboratories/Pvt/Ltd's FEI number is 3004449031.
What types of violations has Ramlal Laboratories/Pvt/Ltd received?
Ramlal Laboratories/Pvt/Ltd has been cited for 1 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 Ramlal Laboratories/Pvt/Ltd come from?
All FDA import refusal data for Ramlal Laboratories/Pvt/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.