Abbott Healthcare Pvt Ltd
⚠️ High Risk
FEI: 3008794752 • Dist. Solan, P.O Baddi • INDIA
FEI Number
3008794752
Location
Dist. Solan, P.O Baddi
Country
INDIAAddress
Village Bhatauli Kurd, Himachal Prades, Dist. Solan, P.O Baddi, 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 |
|---|---|---|---|
| 4/15/2024 | 63ECB13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 4/15/2024 | 61TCB16PROCHLORPERAZINE MALEATE (ANTI-EMETIC/NAUSEANT) | Division of Southeast Imports (DSEI) | |
| 6/22/2021 | 61JDB09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2021 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/29/2019 | 56KDY99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2014 | 65FCK06WATER, PURIFIED (EYEWASH) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Abbott Healthcare Pvt Ltd's FDA import refusal history?
Abbott Healthcare Pvt Ltd (FEI: 3008794752) has 6 FDA import refusal record(s) in our database, spanning from 3/20/2014 to 4/15/2024.
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. Abbott Healthcare Pvt Ltd's FEI number is 3008794752.
What types of violations has Abbott Healthcare Pvt Ltd received?
Abbott Healthcare Pvt Ltd 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 Abbott Healthcare Pvt Ltd come from?
All FDA import refusal data for Abbott Healthcare 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.