CarePluss Pharma S. de R.L. de C.V.
⚠️ Moderate Risk
FEI: 3010164224 • Tijuana, Baja California • MEXICO
FEI Number
3010164224
Location
Tijuana, Baja California
Country
MEXICOAddress
Avenida Los Charros 5 A, Col. Jose Sandoval, Tijuana, Tijuana, Baja California, Mexico
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).
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.
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 CarePluss Pharma S. de R.L. de C.V.'s FDA import refusal history?
CarePluss Pharma S. de R.L. de C.V. (FEI: 3010164224) has 2 FDA import refusal record(s) in our database, spanning from 12/13/2012 to 12/13/2012.
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. CarePluss Pharma S. de R.L. de C.V.'s FEI number is 3010164224.
What types of violations has CarePluss Pharma S. de R.L. de C.V. received?
CarePluss Pharma S. de R.L. de C.V. 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 CarePluss Pharma S. de R.L. de C.V. come from?
All FDA import refusal data for CarePluss Pharma S. de R.L. de C.V. 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.