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Glowacal Mfg Corp

⚠️ High Risk

FEI: 3007052659 • San Juan, Rizal Province • PHILIPPINES

FEI

FEI Number

3007052659

📍

Location

San Juan, Rizal Province

🇵🇭
🏢

Address

7-A Bonifacio Ave Brgy, , Cainta, San Juan, Rizal Province, Philippines

High Risk

FDA Import Risk Assessment

53.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
1
Unique Violations
2/23/2009
Latest Refusal
2/23/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

757×

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
2/23/2009
61HIY99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Baltimore District Office (BLT-DO)
2/23/2009
61HIY99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Baltimore District Office (BLT-DO)
2/23/2009
61HIY99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Baltimore District Office (BLT-DO)
2/23/2009
61HIY99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Baltimore District Office (BLT-DO)
2/23/2009
61HIY99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Baltimore District Office (BLT-DO)
2/23/2009
61HIY99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Baltimore District Office (BLT-DO)
2/23/2009
61HIY99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Glowacal Mfg Corp's FDA import refusal history?

Glowacal Mfg Corp (FEI: 3007052659) has 7 FDA import refusal record(s) in our database, spanning from 2/23/2009 to 2/23/2009.

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. Glowacal Mfg Corp's FEI number is 3007052659.

What types of violations has Glowacal Mfg Corp received?

Glowacal Mfg Corp 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 Glowacal Mfg Corp come from?

All FDA import refusal data for Glowacal Mfg 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.