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Dr. Mn Custodio

⚠️ Moderate Risk

FEI: 3005908411 • Butnam City • PHILIPPINES

FEI

FEI Number

3005908411

📍

Location

Butnam City

🇵🇭
🏢

Address

Unknown Street, , Butnam City, , Philippines

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
10/25/2006
Latest Refusal
10/25/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1186×

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
10/25/2006
56JDL20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
118NOT LISTED
San Francisco District Office (SAN-DO)
10/25/2006
56JDL20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
118NOT LISTED
San Francisco District Office (SAN-DO)
10/25/2006
56JDL20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
118NOT LISTED
San Francisco District Office (SAN-DO)
10/25/2006
56JDL20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
118NOT LISTED
San Francisco District Office (SAN-DO)
10/25/2006
65LKJ15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT)
118NOT LISTED
San Francisco District Office (SAN-DO)
10/25/2006
63VBY99DEPIGMENTOR N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Dr. Mn Custodio's FDA import refusal history?

Dr. Mn Custodio (FEI: 3005908411) has 6 FDA import refusal record(s) in our database, spanning from 10/25/2006 to 10/25/2006.

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. Dr. Mn Custodio's FEI number is 3005908411.

What types of violations has Dr. Mn Custodio received?

Dr. Mn Custodio 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 Dr. Mn Custodio come from?

All FDA import refusal data for Dr. Mn Custodio 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.