PEDRO MORENO
⚠️ High Risk
FEI: 3030110027 • Taxco De Alarcon, Guerrero • MEXICO
FEI Number
3030110027
Location
Taxco De Alarcon, Guerrero
Country
MEXICOAddress
Avenida De Los Plateros # 28, Col. Taxco De Alarcon Centro, Taxco De Alarcon, Taxco De Alarcon, Guerrero, 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
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.
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 |
|---|---|---|---|
| 2/5/2024 | 54ACI05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 54AMI05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 60KRY03BOLDENONE UNDECYLENATE (ANABOLIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 60NQY04METHYLTESTOSTERONE (ANDROGEN) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 65PQY02SILDENAFIL CITRATE (REGULATOR) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 64LRY31FLUOROMETHOLONE (GLUCOCORTICOID) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 64LRY40HYDROCORTISONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 60ZRY99ANTIPARASITIC, N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PEDRO MORENO's FDA import refusal history?
PEDRO MORENO (FEI: 3030110027) has 8 FDA import refusal record(s) in our database, spanning from 2/5/2024 to 2/5/2024.
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. PEDRO MORENO's FEI number is 3030110027.
What types of violations has PEDRO MORENO received?
PEDRO MORENO 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 PEDRO MORENO come from?
All FDA import refusal data for PEDRO MORENO 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.