Carepluss Pharma Sa De Cv
⚠️ Moderate Risk
FEI: 3009557982 • Tijuana, Baja California • MEXICO
FEI Number
3009557982
Location
Tijuana, Baja California
Country
MEXICOAddress
Via Rapida Oriente No. 11812-2B, Col. Mineral de Santa Fe, 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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
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.
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 |
|---|---|---|---|
| 4/19/2013 | 65LBJ99PROTECTANT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/19/2013 | 65LBJ99PROTECTANT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/31/2013 | 66GBJ25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | 336INCONSPICU | Southwest Import District Office (SWI-DO) |
| 1/31/2013 | 66GBJ25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | 336INCONSPICU | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Carepluss Pharma Sa De Cv's FDA import refusal history?
Carepluss Pharma Sa De Cv (FEI: 3009557982) has 4 FDA import refusal record(s) in our database, spanning from 1/31/2013 to 4/19/2013.
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 Sa De Cv's FEI number is 3009557982.
What types of violations has Carepluss Pharma Sa De Cv received?
Carepluss Pharma Sa De Cv 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 Carepluss Pharma Sa De Cv come from?
All FDA import refusal data for Carepluss Pharma Sa De Cv 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.