M/S Eaststar Manufacturing
⚠️ Moderate Risk
FEI: 3005379896 • Ludhiana, Punjab • INDIA
FEI Number
3005379896
Location
Ludhiana, Punjab
Country
INDIAAddress
20c, , Ludhiana, Punjab, 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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
USUAL NAME
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/18/2007 | 28AGT29MUSTARD, WHOLE (SPICE) | 328USUAL NAME | San Francisco District Office (SAN-DO) |
| 4/18/2007 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | San Francisco District Office (SAN-DO) | |
| 4/10/2007 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 4/10/2007 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 4/10/2007 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 4/10/2007 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is M/S Eaststar Manufacturing's FDA import refusal history?
M/S Eaststar Manufacturing (FEI: 3005379896) has 6 FDA import refusal record(s) in our database, spanning from 4/10/2007 to 4/18/2007.
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. M/S Eaststar Manufacturing's FEI number is 3005379896.
What types of violations has M/S Eaststar Manufacturing received?
M/S Eaststar Manufacturing has been cited for 5 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 M/S Eaststar Manufacturing come from?
All FDA import refusal data for M/S Eaststar Manufacturing 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.