Sentiss Pharma Pvt. Ltd.
⚠️ High Risk
FEI: 3008250236 • District Solan, Himachal Pradesh • INDIA
FEI Number
3008250236
Location
District Solan, Himachal Pradesh
Country
INDIAAddress
Village Khera Nihla, Tehsil Nalargarh, District Solan, Himachal Pradesh, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 Sentiss Pharma Pvt. Ltd.'s FDA import refusal history?
Sentiss Pharma Pvt. Ltd. (FEI: 3008250236) has 1 FDA import refusal record(s) in our database, spanning from 10/7/2025 to 10/7/2025.
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. Sentiss Pharma Pvt. Ltd.'s FEI number is 3008250236.
What types of violations has Sentiss Pharma Pvt. Ltd. received?
Sentiss Pharma Pvt. Ltd. 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 Sentiss Pharma Pvt. Ltd. come from?
All FDA import refusal data for Sentiss Pharma 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.