PCI San Diego, Inc.
⚠️ High Risk
FEI: 3004575449 • San Diego, CA • UNITED STATES
FEI Number
3004575449
Location
San Diego, CA
Country
UNITED STATESAddress
11040 Roselle St, , San Diego, CA, United States
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).
Refusal History
Frequently Asked Questions
What is PCI San Diego, Inc.'s FDA import refusal history?
PCI San Diego, Inc. (FEI: 3004575449) has 2 FDA import refusal record(s) in our database, spanning from 2/21/2012 to 7/29/2025.
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. PCI San Diego, Inc.'s FEI number is 3004575449.
What types of violations has PCI San Diego, Inc. received?
PCI San Diego, Inc. has been cited for 1 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 PCI San Diego, Inc. come from?
All FDA import refusal data for PCI San Diego, Inc. 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.