Serum Institute of India Private Ltd.
⚠️ High Risk
FEI: 3020223359 • Pune, Maharashtra • INDIA
FEI Number
3020223359
Location
Pune, Maharashtra
Country
INDIAAddress
S. No. 105-110, Manjari Bk, Pune Zone 3, , Pune, Maharashtra, 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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2023 | 57HH32BCG VACCINE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 12/22/2014 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/16/2012 | 57IH17MEASLES, MUMPS, RUBELLA VIRUS VACCINE | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 8/16/2012 | 57CH18RUBELLA VIRUS VACCINE | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 8/16/2012 | 57CH03MEASLE VIRUS VACCINE | 71NO LICENSE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Serum Institute of India Private Ltd.'s FDA import refusal history?
Serum Institute of India Private Ltd. (FEI: 3020223359) has 5 FDA import refusal record(s) in our database, spanning from 8/16/2012 to 9/5/2023.
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. Serum Institute of India Private Ltd.'s FEI number is 3020223359.
What types of violations has Serum Institute of India Private Ltd. received?
Serum Institute of India Private 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 Serum Institute of India Private Ltd. come from?
All FDA import refusal data for Serum Institute of India Private 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.