Tulip Lab Pvt Ltd
⚠️ Moderate Risk
FEI: 3005151769 • Mumbai, Maharashtra • INDIA
FEI Number
3005151769
Location
Mumbai, Maharashtra
Country
INDIAAddress
215 Anand Raj Indl Estate, L B S Marg, Mumbai, Maharashtra, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2006 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 10/4/2006 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 10/4/2006 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 10/4/2006 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/6/2005 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 6/17/2005 | 78NHUEXTENDER, PENILE, MECHANICAL | Cincinnati District Office (CIN-DO) | |
| 6/17/2005 | 78NHUEXTENDER, PENILE, MECHANICAL | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Tulip Lab Pvt Ltd's FDA import refusal history?
Tulip Lab Pvt Ltd (FEI: 3005151769) has 7 FDA import refusal record(s) in our database, spanning from 6/17/2005 to 10/4/2006.
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. Tulip Lab Pvt Ltd's FEI number is 3005151769.
What types of violations has Tulip Lab Pvt Ltd received?
Tulip Lab Pvt Ltd has been cited for 4 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 Tulip Lab Pvt Ltd come from?
All FDA import refusal data for Tulip Lab 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.