Scitech Health Care Pvt Ltc
⚠️ Moderate Risk
FEI: 3005610283 • Mumbai • INDIA
FEI Number
3005610283
Location
Mumbai
Country
INDIAAddress
Patel Terrace, Jijamata Rdandheri East, , Mumbai, , 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2007 | 56KCS11CHLORAMPHENICOL PALMITATE | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Scitech Health Care Pvt Ltc's FDA import refusal history?
Scitech Health Care Pvt Ltc (FEI: 3005610283) has 1 FDA import refusal record(s) in our database, spanning from 7/11/2007 to 7/11/2007.
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. Scitech Health Care Pvt Ltc's FEI number is 3005610283.
What types of violations has Scitech Health Care Pvt Ltc received?
Scitech Health Care Pvt Ltc has been cited for 1 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 Scitech Health Care Pvt Ltc come from?
All FDA import refusal data for Scitech Health Care Pvt Ltc 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.