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P.D.C. Factory No. 3

⚠️ Moderate Risk

FEI: 2000026565 • Vientiane, LA-VI • LAOS

FEI

FEI Number

2000026565

📍

Location

Vientiane, LA-VI

🇱🇦

Country

LAOS
🏢

Address

Km 9 Thadeua Road, , Vientiane, LA-VI, Laos

Moderate Risk

FDA Import Risk Assessment

47.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
2/22/2007
Latest Refusal
2/22/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

754×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
2/22/2007
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/22/2007
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/22/2007
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/22/2007
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is P.D.C. Factory No. 3's FDA import refusal history?

P.D.C. Factory No. 3 (FEI: 2000026565) has 4 FDA import refusal record(s) in our database, spanning from 2/22/2007 to 2/22/2007.

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. P.D.C. Factory No. 3's FEI number is 2000026565.

What types of violations has P.D.C. Factory No. 3 received?

P.D.C. Factory No. 3 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 P.D.C. Factory No. 3 come from?

All FDA import refusal data for P.D.C. Factory No. 3 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.