Aero Pharma (Silvassa)
⚠️ Moderate Risk
FEI: 3006410553 • Silvassa, Dadra And Nagar Haveli • INDIA
FEI Number
3006410553
Location
Silvassa, Dadra And Nagar Haveli
Country
INDIAAddress
127/1 Preeti Indl, Amli, Silvassa, Dadra And Nagar Haveli, 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
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 10/10/2007 | 53CK06MASCARA (EYE MAKEUP PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 9/25/2007 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Aero Pharma (Silvassa)'s FDA import refusal history?
Aero Pharma (Silvassa) (FEI: 3006410553) has 3 FDA import refusal record(s) in our database, spanning from 9/25/2007 to 3/28/2014.
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. Aero Pharma (Silvassa)'s FEI number is 3006410553.
What types of violations has Aero Pharma (Silvassa) received?
Aero Pharma (Silvassa) 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 Aero Pharma (Silvassa) come from?
All FDA import refusal data for Aero Pharma (Silvassa) 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.