Psicofarma, SA DE CV
⚠️ High Risk
FEI: 3004553280 • Rancheria San Manuel Tlalpan, Tlaxcala • MEXICO
FEI Number
3004553280
Location
Rancheria San Manuel Tlalpan, Tlaxcala
Country
MEXICOAddress
Calzada De Tlalpan No 4369, Hueyotlipan, Rancheria San Manuel Tlalpan, Tlaxcala, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/21/2023 | 61KCY99ANTI-CHOLINERGIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/21/2023 | 62JDY09LEVODOPA (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2023 | 65LAY16HYDROXYPROPYL CELLULOSE (PROTECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/11/2022 | 66NCY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2022 | 64LCK19DEXAMETHASONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 6/17/2022 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/28/2019 | 61NCA32IMIPRAMINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Psicofarma, SA DE CV's FDA import refusal history?
Psicofarma, SA DE CV (FEI: 3004553280) has 8 FDA import refusal record(s) in our database, spanning from 10/28/2019 to 12/19/2023.
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. Psicofarma, SA DE CV's FEI number is 3004553280.
What types of violations has Psicofarma, SA DE CV received?
Psicofarma, SA DE CV 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 Psicofarma, SA DE CV come from?
All FDA import refusal data for Psicofarma, 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.