UNIVED HEALTHCARE PRODUCTS PRIVATE LIMITED
⚠️ Moderate Risk
FEI: 3013438377 • Vasai, Maharashtra • INDIA
FEI Number
3013438377
Location
Vasai, Maharashtra
Country
INDIAAddress
12 12a Sethia Industrial Park, Unit 11; Waliv Village, Vasai, 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
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
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).
Refusal History
Frequently Asked Questions
What is UNIVED HEALTHCARE PRODUCTS PRIVATE LIMITED's FDA import refusal history?
UNIVED HEALTHCARE PRODUCTS PRIVATE LIMITED (FEI: 3013438377) has 1 FDA import refusal record(s) in our database, spanning from 7/1/2019 to 7/1/2019.
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. UNIVED HEALTHCARE PRODUCTS PRIVATE LIMITED's FEI number is 3013438377.
What types of violations has UNIVED HEALTHCARE PRODUCTS PRIVATE LIMITED received?
UNIVED HEALTHCARE PRODUCTS PRIVATE 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 UNIVED HEALTHCARE PRODUCTS PRIVATE LIMITED come from?
All FDA import refusal data for UNIVED HEALTHCARE PRODUCTS 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.