Abbott Health Care Private Limited
⚠️ Moderate Risk
FEI: 3010180035 • Bharuch, Gujarat • INDIA
FEI Number
3010180035
Location
Bharuch, Gujarat
Country
INDIAAddress
Plot 901/9, Jhagadia Gidc, , Bharuch, Gujarat, 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
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.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/6/2023 | 41YHN99DIETARY CONVENTIONAL FOODS, N.E.C. | 482NUTRIT LBL | Division of Northeast Imports (DNEI) |
| 12/6/2023 | 41YHN99DIETARY CONVENTIONAL FOODS, N.E.C. | 482NUTRIT LBL | Division of Northeast Imports (DNEI) |
| 11/20/2023 | 40PGT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Abbott Health Care Private Limited's FDA import refusal history?
Abbott Health Care Private Limited (FEI: 3010180035) has 3 FDA import refusal record(s) in our database, spanning from 11/20/2023 to 12/6/2023.
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 Health Care Private Limited's FEI number is 3010180035.
What types of violations has Abbott Health Care Private Limited received?
Abbott Health Care Private Limited 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 Health Care Private Limited come from?
All FDA import refusal data for Abbott Health Care Private 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.