Abbott Healthcare Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3005505872 • Mumbai, Maharashtra • INDIA
FEI Number
3005505872
Location
Mumbai, Maharashtra
Country
INDIAAddress
4 Corporate Park, Sion Trombay Road, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/22/2021 | 61PDY34INSULIN BIOSYNTHETIC HUMAN & SUSP ISOPHANE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2017 | 61MDA42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/23/2015 | 61JDA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/27/2006 | 54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Abbott Healthcare Pvt. Ltd.'s FDA import refusal history?
Abbott Healthcare Pvt. Ltd. (FEI: 3005505872) has 4 FDA import refusal record(s) in our database, spanning from 3/27/2006 to 7/22/2021.
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 3005505872.
What types of violations has Abbott Healthcare Pvt. Ltd. received?
Abbott Healthcare Pvt. 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 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.