Flagship Biotech International
⚠️ High Risk
FEI: 3010825631 • Thane, Maharashtra • INDIA
FEI Number
3010825631
Location
Thane, Maharashtra
Country
INDIAAddress
71 Plot No 70, Intop Heights, Thane, 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).
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 |
|---|---|---|---|
| 6/23/2014 | 61EAQ11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 60QAK79BUPIVACAINE HYDROCHLORIDE (ANESTHETIC) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 61WAO18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 63BAQ26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 60QAY40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 63BAQ26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 61EAQ11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 60QAK79BUPIVACAINE HYDROCHLORIDE (ANESTHETIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 61WAO18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 60QAY40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Flagship Biotech International's FDA import refusal history?
Flagship Biotech International (FEI: 3010825631) has 12 FDA import refusal record(s) in our database, spanning from 6/23/2014 to 6/23/2014.
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. Flagship Biotech International's FEI number is 3010825631.
What types of violations has Flagship Biotech International received?
Flagship Biotech International 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 Flagship Biotech International come from?
All FDA import refusal data for Flagship Biotech International 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.