Health Biotech Limited
⚠️ Moderate Risk
FEI: 3011460262 • Baddi, Himachal Pradesh • INDIA
FEI Number
3011460262
Location
Baddi, Himachal Pradesh
Country
INDIAAddress
Baddi - Nalagarh Road, Near Clark Hotel, , Baddi, Himachal Pradesh, 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).
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/13/2018 | 60NCL19TESTOSTERONE PROPIONATE (ANDROGEN) | Division of Southeast Imports (DSEI) | |
| 6/30/2016 | 60NCL16TESTOSTERONE ENANTHATE (ANDROGEN) | Division of Southeast Imports (DSEI) | |
| 3/24/2016 | 64MDZ04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Health Biotech Limited's FDA import refusal history?
Health Biotech Limited (FEI: 3011460262) has 3 FDA import refusal record(s) in our database, spanning from 3/24/2016 to 4/13/2018.
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. Health Biotech Limited's FEI number is 3011460262.
What types of violations has Health Biotech Limited received?
Health Biotech Limited 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 Health Biotech Limited come from?
All FDA import refusal data for Health Biotech Limited 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.