Alkaloids Bioactives Private Ltd
⚠️ Moderate Risk
FEI: 3004443761 • Medchal-Malkajgiri, Telangana • INDIA
FEI Number
3004443761
Location
Medchal-Malkajgiri, Telangana
Country
INDIAAddress
834(P) Medchal Shamirpet Road, Medchal Mandal, , Medchal-Malkajgiri, Telangana, 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
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).
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2015 | 61TSY29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | Chicago District Office (CHI-DO) | |
| 8/14/2015 | 61TSY29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | Chicago District Office (CHI-DO) | |
| 10/24/2014 | 60LCL99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/21/2014 | 60LCL99ANALGESIC, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2009 | 61TCZ29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Alkaloids Bioactives Private Ltd's FDA import refusal history?
Alkaloids Bioactives Private Ltd (FEI: 3004443761) has 5 FDA import refusal record(s) in our database, spanning from 4/17/2009 to 8/14/2015.
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. Alkaloids Bioactives Private Ltd's FEI number is 3004443761.
What types of violations has Alkaloids Bioactives Private Ltd received?
Alkaloids Bioactives Private Ltd has been cited for 5 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 Alkaloids Bioactives Private Ltd come from?
All FDA import refusal data for Alkaloids Bioactives Private 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.