PCAS
⚠️ Moderate Risk
FEI: 3002808156 • Limay, Yvelines • FRANCE
FEI Number
3002808156
Location
Limay, Yvelines
Country
FRANCEAddress
19 route de Meulan, , Limay, Yvelines, France
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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2012 | 62MRR05TRIMEPRAZINE TARTRATE (ANTI-PRURITIC) | 72NEW VET DR | San Francisco District Office (SAN-DO) |
| 2/27/2012 | 62MQR05TRIMEPRAZINE TARTRATE (ANTI-PRURITIC) | 72NEW VET DR | San Francisco District Office (SAN-DO) |
| 6/2/2005 | 61MCS35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is PCAS's FDA import refusal history?
PCAS (FEI: 3002808156) has 3 FDA import refusal record(s) in our database, spanning from 6/2/2005 to 2/27/2012.
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. PCAS's FEI number is 3002808156.
What types of violations has PCAS received?
PCAS has been cited for 2 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 PCAS come from?
All FDA import refusal data for PCAS 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.