Pentavox International
✅ Low Risk
FEI: 3004826618 • Ludhiana, Punjab • INDIA
FEI Number
3004826618
Location
Ludhiana, Punjab
Country
INDIAAddress
479 Sangat Road, , Ludhiana, Punjab, India
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/16/2020 | 76EFWTOOTHBRUSH, MANUAL | Division of West Coast Imports (DWCI) | |
| 10/16/2007 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/16/2007 | 54FEJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pentavox International's FDA import refusal history?
Pentavox International (FEI: 3004826618) has 3 FDA import refusal record(s) in our database, spanning from 10/16/2007 to 4/16/2020.
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. Pentavox International's FEI number is 3004826618.
What types of violations has Pentavox International received?
Pentavox International has been cited for 5 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 Pentavox International come from?
All FDA import refusal data for Pentavox 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.