ImportRefusal LogoImportRefusal

Acta Products Corporation

⚠️ Moderate Risk

FEI: 3005641825 • Sunnyvale, CA • UNITED STATES

FEI

FEI Number

3005641825

📍

Location

Sunnyvale, CA

🇺🇸
🏢

Address

380 N Pastoria Ave, , Sunnyvale, CA, United States

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/15/2010
Latest Refusal
10/15/2010
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

3242×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4882×

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.

Refusal History

DateProductViolationsDivision
10/15/2010
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
324NO ENGLISH
488HEALTH C
Los Angeles District Office (LOS-DO)
10/15/2010
54YCY02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
324NO ENGLISH
488HEALTH C
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Acta Products Corporation's FDA import refusal history?

Acta Products Corporation (FEI: 3005641825) has 2 FDA import refusal record(s) in our database, spanning from 10/15/2010 to 10/15/2010.

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. Acta Products Corporation's FEI number is 3005641825.

What types of violations has Acta Products Corporation received?

Acta Products Corporation 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 Acta Products Corporation come from?

All FDA import refusal data for Acta Products Corporation 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.