WALLAC OY PERKINELMER
⚠️ Moderate Risk
FEI: 3002808498 • Turku, Southwest Finland • FINLAND
FEI Number
3002808498
Location
Turku, Southwest Finland
Country
FINLANDAddress
Mustionkatu 6, , Turku, Southwest Finland, Finland
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2026 | 75NAKSYSTEM, TEST, BIOTINIDASE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/16/2010 | 82DCEFAB, ANTIGEN, ANTISERUM, CONTROL | 341REGISTERED | New York District Office (NYK-DO) |
| 8/31/2004 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is WALLAC OY PERKINELMER's FDA import refusal history?
WALLAC OY PERKINELMER (FEI: 3002808498) has 3 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 1/9/2026.
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. WALLAC OY PERKINELMER's FEI number is 3002808498.
What types of violations has WALLAC OY PERKINELMER received?
WALLAC OY PERKINELMER 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 WALLAC OY PERKINELMER come from?
All FDA import refusal data for WALLAC OY PERKINELMER 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.