Polimeros y Servicios S.A.
⚠️ Moderate Risk
FEI: 3011778211 • Tibas, San Jose • COSTA RICA
FEI Number
3011778211
Location
Tibas, San Jose
Country
COSTA RICAAddress
Parque Industrial Condal, Calle Pantano, Tibas, San Jose, Costa Rica
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
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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 Polimeros y Servicios S.A.'s FDA import refusal history?
Polimeros y Servicios S.A. (FEI: 3011778211) has 1 FDA import refusal record(s) in our database, spanning from 3/12/2019 to 3/12/2019.
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. Polimeros y Servicios S.A.'s FEI number is 3011778211.
What types of violations has Polimeros y Servicios S.A. received?
Polimeros y Servicios S.A. 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 Polimeros y Servicios S.A. come from?
All FDA import refusal data for Polimeros y Servicios S.A. 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.