ImportRefusal LogoImportRefusal

Laboratoire SyMa Inc

⚠️ Moderate Risk

FEI: 3007865110 • Repentigny, Qc • CANADA

FEI

FEI Number

3007865110

📍

Location

Repentigny, Qc

🇨🇦

Country

CANADA
🏢

Address

Rue De Normandie, , Repentigny, Qc, Canada

Moderate Risk

FDA Import Risk Assessment

29.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
11/2/2009
Latest Refusal
11/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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).

3354×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
11/2/2009
62HAL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
335LACKS N/C
New York District Office (NYK-DO)
11/2/2009
62HAL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
335LACKS N/C
New York District Office (NYK-DO)
11/2/2009
62HAL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
335LACKS N/C
New York District Office (NYK-DO)
11/2/2009
62HAL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
335LACKS N/C
New York District Office (NYK-DO)

Frequently Asked Questions

What is Laboratoire SyMa Inc's FDA import refusal history?

Laboratoire SyMa Inc (FEI: 3007865110) has 4 FDA import refusal record(s) in our database, spanning from 11/2/2009 to 11/2/2009.

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. Laboratoire SyMa Inc's FEI number is 3007865110.

What types of violations has Laboratoire SyMa Inc received?

Laboratoire SyMa 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 Laboratoire SyMa Inc come from?

All FDA import refusal data for Laboratoire SyMa 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.