Schott Kaisha Private Limited
✅ Low Risk
FEI: 3007523336 • Daman • INDIA
FEI Number
3007523336
Location
Daman
Country
INDIAAddress
Survey 50/4, Kadaiya Village, Post Bhimpore, Daman, , India
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Schott Kaisha Private Limited's FDA import refusal history?
Schott Kaisha Private Limited (FEI: 3007523336) has 1 FDA import refusal record(s) in our database, spanning from 7/13/2009 to 7/13/2009.
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. Schott Kaisha Private Limited's FEI number is 3007523336.
What types of violations has Schott Kaisha Private Limited received?
Schott Kaisha 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 Schott Kaisha Private Limited come from?
All FDA import refusal data for Schott Kaisha 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.