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ONTRA LABORATORIES, INC.

⚠️ Moderate Risk

FEI: 3003392028 • Baldwin Park, CA • UNITED STATES

FEI

FEI Number

3003392028

📍

Location

Baldwin Park, CA

🇺🇸
🏢

Address

WEST COAST BRANCH, 13111-H BROOKS DRIVE, Baldwin Park, CA, United States

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/5/2001
Latest Refusal
10/5/2001
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

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
10/5/2001
54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
488HEALTH C
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is ONTRA LABORATORIES, INC.'s FDA import refusal history?

ONTRA LABORATORIES, INC. (FEI: 3003392028) has 1 FDA import refusal record(s) in our database, spanning from 10/5/2001 to 10/5/2001.

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. ONTRA LABORATORIES, INC.'s FEI number is 3003392028.

What types of violations has ONTRA LABORATORIES, INC. received?

ONTRA LABORATORIES, 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 ONTRA LABORATORIES, INC. come from?

All FDA import refusal data for ONTRA LABORATORIES, 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.