Apollo Hospitals Enterprise
⚠️ Moderate Risk
FEI: 3004740421 • Kilpauk Chennai • INDIA
FEI Number
3004740421
Location
Kilpauk Chennai
Country
INDIAAddress
475 -B Kilpauk Garden Rd, , Kilpauk Chennai, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 |
|---|---|---|---|
| 10/22/2004 | 61PCB99ANTI-DIABETIC N.E.C. | New York District Office (NYK-DO) | |
| 10/22/2004 | 61PCB09GLIPIZIDE (ANTI-DIABETIC) | New York District Office (NYK-DO) | |
| 10/22/2004 | 61PCB26METFORMIN (ANTI-DIABETIC) | New York District Office (NYK-DO) | |
| 10/22/2004 | 54YGE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 10/22/2004 | 54AEB90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Apollo Hospitals Enterprise's FDA import refusal history?
Apollo Hospitals Enterprise (FEI: 3004740421) has 5 FDA import refusal record(s) in our database, spanning from 10/22/2004 to 10/22/2004.
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. Apollo Hospitals Enterprise's FEI number is 3004740421.
What types of violations has Apollo Hospitals Enterprise received?
Apollo Hospitals Enterprise 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 Apollo Hospitals Enterprise come from?
All FDA import refusal data for Apollo Hospitals Enterprise 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.