Harika Foods & Innovations Ltd
⚠️ Moderate Risk
FEI: 3007393544 • Hyderabad • INDIA
FEI Number
3007393544
Location
Hyderabad
Country
INDIAAddress
Daisy 43 Serene Country, , Hyderabad, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2012 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | Chicago District Office (CHI-DO) | |
| 5/3/2012 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Chicago District Office (CHI-DO) | |
| 5/3/2012 | 66VCO99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 6/10/2010 | 03YGY99OTHER BAKERY PRODUCTS, N.E.C. | 249FILTHY | Chicago District Office (CHI-DO) |
| 3/25/2009 | 52AMD99KITCHEN AND TABLEWARE, N.E.C., (FOODWARE, COOKWARE & TABLEWARE) | 238UNSAFE ADD | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Harika Foods & Innovations Ltd's FDA import refusal history?
Harika Foods & Innovations Ltd (FEI: 3007393544) has 5 FDA import refusal record(s) in our database, spanning from 3/25/2009 to 5/3/2012.
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. Harika Foods & Innovations Ltd's FEI number is 3007393544.
What types of violations has Harika Foods & Innovations Ltd received?
Harika Foods & Innovations Ltd 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 Harika Foods & Innovations Ltd come from?
All FDA import refusal data for Harika Foods & Innovations Ltd 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.