Therma Cosmetica Inc.
⚠️ Moderate Risk
FEI: 3007945400 • Manila, National Capital Region • PHILIPPINES
FEI Number
3007945400
Location
Manila, National Capital Region
Country
PHILIPPINESAddress
1724 A. Mabini Street, Barangay 699, , Manila, National Capital Region, Philippines
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
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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
Frequently Asked Questions
What is Therma Cosmetica Inc.'s FDA import refusal history?
Therma Cosmetica Inc. (FEI: 3007945400) has 1 FDA import refusal record(s) in our database, spanning from 12/15/2009 to 12/15/2009.
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. Therma Cosmetica Inc.'s FEI number is 3007945400.
What types of violations has Therma Cosmetica Inc. received?
Therma Cosmetica Inc. has been cited for 4 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 Therma Cosmetica Inc. come from?
All FDA import refusal data for Therma Cosmetica Inc. 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.