Glaxo Smith Kline Consumer
⚠️ Moderate Risk
FEI: 3005353370 • Secunderabad • INDIA
FEI Number
3005353370
Location
Secunderabad
Country
INDIAAddress
94d Kompally Secunderabad, , Secunderabad, , 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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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.
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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 |
|---|---|---|---|
| 1/21/2010 | 34HHT99CHOCOLATE AND COCOA BEVERAGE BASE, N.E.C. | 482NUTRIT LBL | San Francisco District Office (SAN-DO) |
| 1/21/2010 | 14AET06FILLED MILK, DRIED MILK TYPE PRODUCT | 482NUTRIT LBL | San Francisco District Office (SAN-DO) |
| 4/10/2009 | 34HHT99CHOCOLATE AND COCOA BEVERAGE BASE, N.E.C. | San Francisco District Office (SAN-DO) | |
| 4/10/2009 | 34HHT99CHOCOLATE AND COCOA BEVERAGE BASE, N.E.C. | San Francisco District Office (SAN-DO) | |
| 11/14/2006 | 34HHT99CHOCOLATE AND COCOA BEVERAGE BASE, N.E.C. | San Francisco District Office (SAN-DO) | |
| 9/7/2006 | 34BFT13SWEET CHOCOLATE AND VEGETABLE FAT COATING (EXCEPT CHOCOLATE CANDY AND CHOCOLATE BEVERAGE BASE) | San Francisco District Office (SAN-DO) | |
| 9/7/2006 | 34BFT13SWEET CHOCOLATE AND VEGETABLE FAT COATING (EXCEPT CHOCOLATE CANDY AND CHOCOLATE BEVERAGE BASE) | San Francisco District Office (SAN-DO) | |
| 8/30/2006 | 60SBR99ANTACID, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/13/2006 | 60SBR99ANTACID, N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/14/2006 | 09CHT99MILK AND CREAM, N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/14/2006 | 29ACT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | San Francisco District Office (SAN-DO) | |
| 2/14/2006 | 09CDT11MILK WITH MULTIVITAMINS ADDED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Glaxo Smith Kline Consumer's FDA import refusal history?
Glaxo Smith Kline Consumer (FEI: 3005353370) has 12 FDA import refusal record(s) in our database, spanning from 2/14/2006 to 1/21/2010.
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. Glaxo Smith Kline Consumer's FEI number is 3005353370.
What types of violations has Glaxo Smith Kline Consumer received?
Glaxo Smith Kline Consumer has been cited for 8 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 Glaxo Smith Kline Consumer come from?
All FDA import refusal data for Glaxo Smith Kline Consumer 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.