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Twenty-First Century Healthcare Fund, L.L.C.

⚠️ Moderate Risk

FEI: 1000160551 • Tempe, AZ • UNITED STATES

FEI

FEI Number

1000160551

📍

Location

Tempe, AZ

🇺🇸
🏢

Address

2119 S Wilson St, , Tempe, AZ, United States

Moderate Risk

FDA Import Risk Assessment

38.6
LowModerateHighCritical

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

Statistics

8
Total Refusals
1
Unique Violations
11/3/2005
Latest Refusal
3/30/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

1188×

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

DateProductViolationsDivision
11/3/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/3/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/3/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/3/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
3/30/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
3/30/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
3/30/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
3/30/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Twenty-First Century Healthcare Fund, L.L.C.'s FDA import refusal history?

Twenty-First Century Healthcare Fund, L.L.C. (FEI: 1000160551) has 8 FDA import refusal record(s) in our database, spanning from 3/30/2005 to 11/3/2005.

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. Twenty-First Century Healthcare Fund, L.L.C.'s FEI number is 1000160551.

What types of violations has Twenty-First Century Healthcare Fund, L.L.C. received?

Twenty-First Century Healthcare Fund, L.L.C. 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 Twenty-First Century Healthcare Fund, L.L.C. come from?

All FDA import refusal data for Twenty-First Century Healthcare Fund, L.L.C. 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.