GlaxoSmithKline Consumer Healthcare Limited
⚠️ Moderate Risk
FEI: 2000006573 • Gurgaon, IN-HR • INDIA
FEI Number
2000006573
Location
Gurgaon, IN-HR
Country
INDIAAddress
DFL Plaza Tower, DFL City Phase !, Gurgaon, IN-HR, 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
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2018 | 30FYY99BEVERAGE BASE OF NON-FRUIT ORIGIN, N.E.C. | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 3/1/2013 | 29CGT99NONALCOHOLIC BEVERAGES, N.E.C. | New York District Office (NYK-DO) | |
| 2/12/2008 | 27YCT07SANDWICH SPREAD (SALAD DRESSING BASED) | Southwest Import District Office (SWI-DO) | |
| 2/12/2008 | 27YCT07SANDWICH SPREAD (SALAD DRESSING BASED) | Southwest Import District Office (SWI-DO) | |
| 3/19/2007 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is GlaxoSmithKline Consumer Healthcare Limited's FDA import refusal history?
GlaxoSmithKline Consumer Healthcare Limited (FEI: 2000006573) has 5 FDA import refusal record(s) in our database, spanning from 3/19/2007 to 12/8/2018.
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. GlaxoSmithKline Consumer Healthcare Limited's FEI number is 2000006573.
What types of violations has GlaxoSmithKline Consumer Healthcare Limited received?
GlaxoSmithKline Consumer Healthcare Limited 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 GlaxoSmithKline Consumer Healthcare Limited come from?
All FDA import refusal data for GlaxoSmithKline Consumer Healthcare Limited 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.