Daxal Cosmetics Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3006127560 • Ahmedabad, Gujarat • INDIA
FEI Number
3006127560
Location
Ahmedabad, Gujarat
Country
INDIAAddress
347 Mahagujarat Ind Estate, Sarkhej Bawla Road; N H 8a, Moraiya, Ahmedabad, Gujarat, 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
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/13/2019 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 11/13/2019 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 11/13/2019 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 12/14/2007 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Daxal Cosmetics Pvt. Ltd.'s FDA import refusal history?
Daxal Cosmetics Pvt. Ltd. (FEI: 3006127560) has 4 FDA import refusal record(s) in our database, spanning from 12/14/2007 to 11/13/2019.
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. Daxal Cosmetics Pvt. Ltd.'s FEI number is 3006127560.
What types of violations has Daxal Cosmetics Pvt. Ltd. received?
Daxal Cosmetics Pvt. Ltd. has been cited for 3 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 Daxal Cosmetics Pvt. Ltd. come from?
All FDA import refusal data for Daxal Cosmetics Pvt. 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.