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Myra Pharmaceutical Inc

⚠️ Moderate Risk

FEI: 3004368213 • San Juan • PHILIPPINES

FEI

FEI Number

3004368213

📍

Location

San Juan

🇵🇭
🏢

Address

41f Bonaventure Plaza, , San Juan, , Philippines

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/29/2007
Latest Refusal
12/1/2006
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1182×

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).

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
11/29/2007
62UPA99ANTI-TUSSIVE/COLD N.E.C.
75UNAPPROVED
Seattle District Office (SEA-DO)
12/1/2006
60CBY99ADRENERGIC N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)
12/1/2006
62GBY41IBUPROFEN (ANTI-INFLAMMATORY)
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Myra Pharmaceutical Inc's FDA import refusal history?

Myra Pharmaceutical Inc (FEI: 3004368213) has 3 FDA import refusal record(s) in our database, spanning from 12/1/2006 to 11/29/2007.

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. Myra Pharmaceutical Inc's FEI number is 3004368213.

What types of violations has Myra Pharmaceutical Inc received?

Myra Pharmaceutical Inc 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 Myra Pharmaceutical Inc come from?

All FDA import refusal data for Myra Pharmaceutical Inc 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.