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Apotek Produktion & Laboratorier AB

✅ Low Risk

FEI: 3004967053 • Kungens Kurva, Stockholms Lan • SWEDEN

FEI

FEI Number

3004967053

📍

Location

Kungens Kurva, Stockholms Lan

🇸🇪

Country

SWEDEN
🏢

Address

Prismavagen 2, , Kungens Kurva, Stockholms Lan, Sweden

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
4/13/2016
Latest Refusal
4/13/2016
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
4/13/2016
53LK06MOISTURIZING (SKIN CARE PREPARATIONS)
473LABELING
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Apotek Produktion & Laboratorier AB's FDA import refusal history?

Apotek Produktion & Laboratorier AB (FEI: 3004967053) has 1 FDA import refusal record(s) in our database, spanning from 4/13/2016 to 4/13/2016.

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. Apotek Produktion & Laboratorier AB's FEI number is 3004967053.

What types of violations has Apotek Produktion & Laboratorier AB received?

Apotek Produktion & Laboratorier AB 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 Apotek Produktion & Laboratorier AB come from?

All FDA import refusal data for Apotek Produktion & Laboratorier AB 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.