Eaststar Manufacturing
⚠️ Moderate Risk
FEI: 3004819587 • Ludhiana • INDIA
FEI Number
3004819587
Location
Ludhiana
Country
INDIAAddress
Eaststar Manufacturing Syndcate200 Brs, , Ludhiana, , 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).
CONTAINER
The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.
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.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/15/2005 | 52AID99KITCHEN AND TABLEWARE, N.E.C., (FOODWARE, COOKWARE & TABLEWARE) | 171CONTAINER | San Francisco District Office (SAN-DO) |
| 4/13/2005 | 60LBJ99ANALGESIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/21/2005 | 25NEE06POTATO, WITH SAUCE | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Eaststar Manufacturing's FDA import refusal history?
Eaststar Manufacturing (FEI: 3004819587) has 3 FDA import refusal record(s) in our database, spanning from 1/21/2005 to 4/15/2005.
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. Eaststar Manufacturing's FEI number is 3004819587.
What types of violations has Eaststar Manufacturing received?
Eaststar Manufacturing 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 Eaststar Manufacturing come from?
All FDA import refusal data for 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.