Chieron Active Ingredients Private Limited
⚠️ Moderate Risk
FEI: 3006897905 • Nellore, Andhra Pradesh • INDIA
FEI Number
3006897905
Location
Nellore, Andhra Pradesh
Country
INDIAAddress
No. 69, Chandrapadiya Village, Vinjamur Mandal, Nellore, Andhra Pradesh, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2015 | 60QCT52TETRACAINE HCL (ANESTHETIC) | 16DIRECTIONS | Division of West Coast Imports (DWCI) |
| 6/12/2014 | 60QCS52TETRACAINE HCL (ANESTHETIC) | New England District Office (NWE-DO) | |
| 5/9/2014 | 60QCS52TETRACAINE HCL (ANESTHETIC) | 16DIRECTIONS | New England District Office (NWE-DO) |
| 2/22/2012 | 60QAY70TETRACAINE (ANESTHETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/5/2010 | 60QIR70TETRACAINE (ANESTHETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Chieron Active Ingredients Private Limited's FDA import refusal history?
Chieron Active Ingredients Private Limited (FEI: 3006897905) has 5 FDA import refusal record(s) in our database, spanning from 1/5/2010 to 2/10/2015.
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. Chieron Active Ingredients Private Limited's FEI number is 3006897905.
What types of violations has Chieron Active Ingredients Private Limited received?
Chieron Active Ingredients Private Limited 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 Chieron Active Ingredients Private Limited come from?
All FDA import refusal data for Chieron Active Ingredients Private Limited 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.