Immucor, Inc.
⚠️ Moderate Risk
FEI: 1034569 • Peachtree Corners, GA • UNITED STATES
FEI Number
1034569
Location
Peachtree Corners, GA
Country
UNITED STATESAddress
3130 Gateway Dr, , Peachtree Corners, GA, United States
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
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2012 | 81KSKSOLUTION, STABILIZED ENZYME | 2380NO PMA/PDP | Atlanta District Office (ATL-DO) |
| 3/6/2012 | 81KSKSOLUTION, STABILIZED ENZYME | 2380NO PMA/PDP | Atlanta District Office (ATL-DO) |
| 3/6/2012 | 81KSGMEDIA, POTENTIATING FOR IN VITRO DIAGNOSTIC USE | 2380NO PMA/PDP | Atlanta District Office (ATL-DO) |
| 3/6/2012 | 81KSXSUBSTANCE, BLOOD GROUPING OF NON-HUMAN ORIGIN FOR IN VITRO DIAGNOSTIC USE | 2380NO PMA/PDP | Atlanta District Office (ATL-DO) |
| 3/6/2012 | 81KSFKIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS | 2380NO PMA/PDP | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Immucor, Inc.'s FDA import refusal history?
Immucor, Inc. (FEI: 1034569) has 5 FDA import refusal record(s) in our database, spanning from 3/6/2012 to 3/6/2012.
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. Immucor, Inc.'s FEI number is 1034569.
What types of violations has Immucor, Inc. received?
Immucor, 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 Immucor, Inc. come from?
All FDA import refusal data for Immucor, 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.