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Parke Davis

⚠️ Moderate Risk

FEI: 3003768309 • Orleans, Loiret • FRANCE

FEI

FEI Number

3003768309

📍

Location

Orleans, Loiret

🇫🇷

Country

FRANCE
🏢

Address

5 Avenue De Concyr, , Orleans, Loiret, France

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/13/2004
Latest Refusal
10/7/2002
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
13.2×10%
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

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

751×

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
4/13/2004
54AEL99VITAMIN, N.E.C.
75UNAPPROVED
Baltimore District Office (BLT-DO)
10/7/2002
54YEL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Parke Davis's FDA import refusal history?

Parke Davis (FEI: 3003768309) has 2 FDA import refusal record(s) in our database, spanning from 10/7/2002 to 4/13/2004.

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. Parke Davis's FEI number is 3003768309.

What types of violations has Parke Davis received?

Parke Davis 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 Parke Davis come from?

All FDA import refusal data for Parke Davis 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.