Giriraj International
⚠️ Moderate Risk
FEI: 3007594904 • Navi Mumbi • INDIA
FEI Number
3007594904
Location
Navi Mumbi
Country
INDIAAddress
Plot No. W-139, M.I.D.Ckhaime, , Navi Mumbi, , 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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
MELAMINE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
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).
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).
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2010 | 53YG99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/20/2010 | 37JCP99SAUCES, N.E.C. | 473LABELING | San Francisco District Office (SAN-DO) |
| 10/20/2010 | 53YG99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/20/2010 | 33EGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 260FALSE | San Francisco District Office (SAN-DO) |
| 10/20/2010 | 37JCP99SAUCES, N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/20/2010 | 29BCE50SOFT DRINK, COLA, CARBONATED | San Francisco District Office (SAN-DO) | |
| 10/20/2010 | 29BCE50SOFT DRINK, COLA, CARBONATED | San Francisco District Office (SAN-DO) | |
| 10/20/2010 | 37JCP99SAUCES, N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/20/2010 | 28SGT03SALT, ROCK (TABLE SALT) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 4/2/2010 | 02GGT08SOYBEAN FLOUR, MEAL, OR POWDER | 3421MELAMINE | San Francisco District Office (SAN-DO) |
| 9/9/2009 | 66YBR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 8/21/2009 | 28AGT99WHOLE SPICE, N.E.C. | 218LIST INGRE | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Giriraj International's FDA import refusal history?
Giriraj International (FEI: 3007594904) has 12 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 10/25/2010.
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. Giriraj International's FEI number is 3007594904.
What types of violations has Giriraj International received?
Giriraj International has been cited for 12 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 Giriraj International come from?
All FDA import refusal data for Giriraj International 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.