Sunways (India) Private Ltd.
⚠️ Moderate Risk
FEI: 3003049733 • Mumbai • INDIA
FEI Number
3003049733
Location
Mumbai
Country
INDIAAddress
Jaiprakash Road No. 2, , Goregaon (East), Mumbai, , 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).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 5/4/2023 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/1/2013 | 63NCK12CARBACHOL (CHOLINERGIC) | New Orleans District Office (NOL-DO) | |
| 11/1/2013 | 88LGYTRYPAN BLUE | New Orleans District Office (NOL-DO) | |
| 11/1/2013 | 86LZPAID, SURGICAL, VISCOELASTIC | New Orleans District Office (NOL-DO) | |
| 11/1/2013 | 86LZPAID, SURGICAL, VISCOELASTIC | New Orleans District Office (NOL-DO) | |
| 8/23/2004 | 86LWLFLUID, INTRAOCULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 11/20/2003 | 79LWDSOLUTION, IRRIGATING, NON-INJECTABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sunways (India) Private Ltd.'s FDA import refusal history?
Sunways (India) Private Ltd. (FEI: 3003049733) has 7 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 5/4/2023.
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. Sunways (India) Private Ltd.'s FEI number is 3003049733.
What types of violations has Sunways (India) Private Ltd. received?
Sunways (India) Private Ltd. has been cited for 4 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 Sunways (India) Private Ltd. come from?
All FDA import refusal data for Sunways (India) Private 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.