Nr Rele
⚠️ High Risk
FEI: 3008948062 • Mumbai, Maharashtra • INDIA
FEI Number
3008948062
Location
Mumbai, Maharashtra
Country
INDIAAddress
18 Gautam Buddha Marg, , Mumbai, Maharashtra, 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 |
|---|---|---|---|
| 7/13/2011 | 62KCF10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/13/2011 | 61ACA04CHLOROQUINE (ANTI-AMEBIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/13/2011 | 65PCJ02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/13/2011 | 62GDF41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/13/2011 | 54YEF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/13/2011 | 54YEF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/13/2011 | 64LCJ19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/13/2011 | 56DCO40NEOMYCIN (AMINOGLYCOSIDES) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nr Rele's FDA import refusal history?
Nr Rele (FEI: 3008948062) has 8 FDA import refusal record(s) in our database, spanning from 7/13/2011 to 7/13/2011.
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. Nr Rele's FEI number is 3008948062.
What types of violations has Nr Rele received?
Nr Rele 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 Nr Rele come from?
All FDA import refusal data for Nr Rele 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.