Ban Labs Ltd
⚠️ Moderate Risk
FEI: 3010867117 • Paonta Sahib • INDIA
FEI Number
3010867117
Location
Paonta Sahib
Country
INDIAAddress
Dhaula Kaun Tehsil Dist: Sirmour H.P., , Paonta Sahib, , 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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/7/2020 | 63WBL99DETERGENT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/11/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/11/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/14/2017 | 66JCH99THYROID HORMONE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2015 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Detroit District Office (DET-DO) |
| 11/17/2014 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/17/2014 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/17/2014 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/17/2014 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Ban Labs Ltd's FDA import refusal history?
Ban Labs Ltd (FEI: 3010867117) has 9 FDA import refusal record(s) in our database, spanning from 11/17/2014 to 2/7/2020.
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. Ban Labs Ltd's FEI number is 3010867117.
What types of violations has Ban Labs Ltd received?
Ban Labs Ltd 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 Ban Labs Ltd come from?
All FDA import refusal data for Ban Labs 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.