Stericon Pharma Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3004983128 • Bommasandra, Karnataka • INDIA
FEI Number
3004983128
Location
Bommasandra, Karnataka
Country
INDIAAddress
Sub Layout Of Plot 9, No 9, Bommasandra, Karnataka, 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
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).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 6/1/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 9/15/2010 | 65FBK06WATER, PURIFIED (EYEWASH) | 27DRUG GMPS | Seattle District Office (SEA-DO) |
| 9/9/2010 | 65FBK06WATER, PURIFIED (EYEWASH) | 27DRUG GMPS | Seattle District Office (SEA-DO) |
| 7/21/2010 | 65FBK06WATER, PURIFIED (EYEWASH) | New York District Office (NYK-DO) | |
| 10/9/2009 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Stericon Pharma Pvt. Ltd.'s FDA import refusal history?
Stericon Pharma Pvt. Ltd. (FEI: 3004983128) has 6 FDA import refusal record(s) in our database, spanning from 10/9/2009 to 2/19/2015.
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. Stericon Pharma Pvt. Ltd.'s FEI number is 3004983128.
What types of violations has Stericon Pharma Pvt. Ltd. received?
Stericon Pharma Pvt. Ltd. has been cited for 7 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 Stericon Pharma Pvt. Ltd. come from?
All FDA import refusal data for Stericon 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.