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S & D Chemicals Ltd

⚠️ Moderate Risk

FEI: 1000443584 • Scarborough, Ontario • CANADA

FEI

FEI Number

1000443584

📍

Location

Scarborough, Ontario

🇨🇦

Country

CANADA
🏢

Address

131 Finchdene Sq, Square/7, Scarborough, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
6
Unique Violations
4/16/2002
Latest Refusal
4/11/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

28801×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

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
4/16/2002
65HCZ02DEXTRAN 70 (PLASMA VOLUME EXTENDER)
75UNAPPROVED
New Orleans District Office (NOL-DO)
4/11/2002
61PDB11GLYBURIDE (ANTI-DIABETIC)
118NOT LISTED
223FALSE
2880RXCOMPOUND
333LACKS FIRM
336INCONSPICU
Detroit District Office (DET-DO)

Frequently Asked Questions

What is S & D Chemicals Ltd's FDA import refusal history?

S & D Chemicals Ltd (FEI: 1000443584) has 2 FDA import refusal record(s) in our database, spanning from 4/11/2002 to 4/16/2002.

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. S & D Chemicals Ltd's FEI number is 1000443584.

What types of violations has S & D Chemicals Ltd received?

S & D Chemicals Ltd has been cited for 6 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 S & D Chemicals Ltd come from?

All FDA import refusal data for S & D Chemicals Ltd 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.