Vitromed Healthcare
⚠️ Moderate Risk
FEI: 3008496443 • Jaipur, Rajasthan • INDIA
FEI Number
3008496443
Location
Jaipur, Rajasthan
Country
INDIAAddress
E - 971 / 972 G-973/974 Phase Iii, Sitapura Industrial Area Road; Biotech Park, Jaipur, Rajasthan, 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).
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.
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 |
|---|---|---|---|
| 2/26/2018 | 30GGI99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/26/2018 | 30GGI99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/26/2018 | 30GGI99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/11/2017 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 7/11/2017 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/24/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Vitromed Healthcare's FDA import refusal history?
Vitromed Healthcare (FEI: 3008496443) has 14 FDA import refusal record(s) in our database, spanning from 11/24/2010 to 2/26/2018.
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. Vitromed Healthcare's FEI number is 3008496443.
What types of violations has Vitromed Healthcare received?
Vitromed Healthcare has been cited for 4 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 Vitromed Healthcare come from?
All FDA import refusal data for Vitromed Healthcare 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.