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Speciosa Specialist

⚠️ Moderate Risk

FEI: 3007111977 • Chicago, IL • UNITED STATES

FEI

FEI Number

3007111977

📍

Location

Chicago, IL

🇺🇸
🏢

Address

833 W Chicago Ave, , Chicago, IL, United States

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

4
Total Refusals
1
Unique Violations
10/2/2008
Latest Refusal
9/22/2008
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

164×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
10/2/2008
66VCL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Cincinnati District Office (CIN-DO)
10/2/2008
66VCL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Cincinnati District Office (CIN-DO)
9/22/2008
66VCR99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Cincinnati District Office (CIN-DO)
9/22/2008
66VCL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Speciosa Specialist's FDA import refusal history?

Speciosa Specialist (FEI: 3007111977) has 4 FDA import refusal record(s) in our database, spanning from 9/22/2008 to 10/2/2008.

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. Speciosa Specialist's FEI number is 3007111977.

What types of violations has Speciosa Specialist received?

Speciosa Specialist 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 Speciosa Specialist come from?

All FDA import refusal data for Speciosa Specialist 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.