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Apothecus Pharmaceutical Corp.

⚠️ Moderate Risk

FEI: 3001746542 • Hicksville, NY • UNITED STATES

FEI

FEI Number

3001746542

📍

Location

Hicksville, NY

🇺🇸
🏢

Address

485 S Broadway Ste 27, , Hicksville, NY, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/31/2002
Latest Refusal
1/31/2002
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1151×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

1181×

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
1/31/2002
65XAY03NONOXYNOL 9 (SPERMATICIDE)
115DR QUALITY
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Apothecus Pharmaceutical Corp.'s FDA import refusal history?

Apothecus Pharmaceutical Corp. (FEI: 3001746542) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2002 to 1/31/2002.

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. Apothecus Pharmaceutical Corp.'s FEI number is 3001746542.

What types of violations has Apothecus Pharmaceutical Corp. received?

Apothecus Pharmaceutical Corp. 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 Apothecus Pharmaceutical Corp. come from?

All FDA import refusal data for Apothecus Pharmaceutical Corp. 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.