Conta Care Ophthalmics Pvt Ltd.
⚠️ Moderate Risk
FEI: 3003816924 • Vadodara, Gujarat • INDIA
FEI Number
3003816924
Location
Vadodara, Gujarat
Country
INDIAAddress
15/A Near, Gandi Mill Compound, Vadodara, Gujarat, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2009 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/8/2009 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/8/2009 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/8/2009 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/8/2009 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/8/2009 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/8/2009 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/9/2005 | 63XIY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 3/14/2005 | 86KYCSTRIP, FLUORESCEIN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Conta Care Ophthalmics Pvt Ltd.'s FDA import refusal history?
Conta Care Ophthalmics Pvt Ltd. (FEI: 3003816924) has 9 FDA import refusal record(s) in our database, spanning from 3/14/2005 to 4/8/2009.
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. Conta Care Ophthalmics Pvt Ltd.'s FEI number is 3003816924.
What types of violations has Conta Care Ophthalmics Pvt Ltd. received?
Conta Care Ophthalmics Pvt Ltd. 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 Conta Care Ophthalmics Pvt Ltd. come from?
All FDA import refusal data for Conta Care Ophthalmics 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.