THYLAKOID BIOTECH PVT LTD
⚠️ Moderate Risk
FEI: 3024775272 • Gandhinagar, Gujarat • INDIA
FEI Number
3024775272
Location
Gandhinagar, Gujarat
Country
INDIAAddress
B1/B2/B3 - 17, , Gandhinagar, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
Refusal History
Frequently Asked Questions
What is THYLAKOID BIOTECH PVT LTD's FDA import refusal history?
THYLAKOID BIOTECH PVT LTD (FEI: 3024775272) has 1 FDA import refusal record(s) in our database, spanning from 1/23/2023 to 1/23/2023.
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. THYLAKOID BIOTECH PVT LTD's FEI number is 3024775272.
What types of violations has THYLAKOID BIOTECH PVT LTD received?
THYLAKOID BIOTECH PVT LTD 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 THYLAKOID BIOTECH PVT LTD come from?
All FDA import refusal data for THYLAKOID BIOTECH PVT LTD 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.