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Lorenzo C Reyes Laboratory Inc

⚠️ Moderate Risk

FEI: 3005118661 • First Bulacan Industria • PHILIPPINES

FEI

FEI Number

3005118661

📍

Location

First Bulacan Industria

🇵🇭
🏢

Address

Lot 9 C, Bl 7, , First Bulacan Industria, , Philippines

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/9/2005
Latest Refusal
6/9/2005
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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

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).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

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
6/9/2005
55QY18YELLOW OINTMENT (PHARMACEUTIC NECESSITY - OINTMENT BASE)
118NOT LISTED
483DRUG NAME
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Lorenzo C Reyes Laboratory Inc's FDA import refusal history?

Lorenzo C Reyes Laboratory Inc (FEI: 3005118661) has 1 FDA import refusal record(s) in our database, spanning from 6/9/2005 to 6/9/2005.

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. Lorenzo C Reyes Laboratory Inc's FEI number is 3005118661.

What types of violations has Lorenzo C Reyes Laboratory Inc received?

Lorenzo C Reyes Laboratory Inc has been cited for 3 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 Lorenzo C Reyes Laboratory Inc come from?

All FDA import refusal data for Lorenzo C Reyes Laboratory 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.