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Atc Mfg. Corp.

⚠️ Moderate Risk

FEI: 3008074341 • Caloocan City • PHILIPPINES

FEI

FEI Number

3008074341

📍

Location

Caloocan City

🇵🇭
🏢

Address

Unknown Street, , Caloocan City, , Philippines

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/16/2010
Latest Refusal
3/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

832×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
3/16/2010
16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
83NO PROCESS
San Francisco District Office (SAN-DO)
3/16/2010
16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
83NO PROCESS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Atc Mfg. Corp.'s FDA import refusal history?

Atc Mfg. Corp. (FEI: 3008074341) has 2 FDA import refusal record(s) in our database, spanning from 3/16/2010 to 3/16/2010.

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. Atc Mfg. Corp.'s FEI number is 3008074341.

What types of violations has Atc Mfg. Corp. received?

Atc 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 Atc Mfg. Corp. come from?

All FDA import refusal data for Atc 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.