Inga Pharmaceuticals
⚠️ Moderate Risk
FEI: 3008327597 • Chennai, Tamil Nadu • INDIA
FEI Number
3008327597
Location
Chennai, Tamil Nadu
Country
INDIAAddress
Plot No.B-1(pt) Phase ll, NH-45 Tambaram, Mepz - Special Economic Zone; Zone A, Chennai, Tamil Nadu, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 Inga Pharmaceuticals's FDA import refusal history?
Inga Pharmaceuticals (FEI: 3008327597) has 1 FDA import refusal record(s) in our database, spanning from 12/19/2021 to 12/19/2021.
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. Inga Pharmaceuticals's FEI number is 3008327597.
What types of violations has Inga Pharmaceuticals received?
Inga Pharmaceuticals 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 Inga Pharmaceuticals come from?
All FDA import refusal data for Inga Pharmaceuticals 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.