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Bodycote Technitrol Inc

⚠️ Moderate Risk

FEI: 3002904333 • Pointe-Claire, Quebec • CANADA

FEI

FEI Number

3002904333

📍

Location

Pointe-Claire, Quebec

🇨🇦

Country

CANADA
🏢

Address

121 Hymus Blvd, , Pointe-Claire, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

31.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
8/30/2004
Latest Refusal
8/30/2004
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

3355×

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
8/30/2004
64LBO38HYDROCORTISONE ACETATE (GLUCOCORTICOID)
118NOT LISTED
335LACKS N/C
New Orleans District Office (NOL-DO)
8/30/2004
64LAK60TRIAMCINOLONE (GLUCOCORTICOID)
118NOT LISTED
335LACKS N/C
New Orleans District Office (NOL-DO)
8/30/2004
68CAY20ANTISEPTIC USED MORE THAN 1 SPECIES
118NOT LISTED
335LACKS N/C
New Orleans District Office (NOL-DO)
8/30/2004
65LBK04BENZOIN (TINCT) (PROTECTANT)
118NOT LISTED
335LACKS N/C
New Orleans District Office (NOL-DO)
8/30/2004
65LAK06CALAMINE (PROTECTANT)
118NOT LISTED
335LACKS N/C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bodycote Technitrol Inc's FDA import refusal history?

Bodycote Technitrol Inc (FEI: 3002904333) has 5 FDA import refusal record(s) in our database, spanning from 8/30/2004 to 8/30/2004.

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. Bodycote Technitrol Inc's FEI number is 3002904333.

What types of violations has Bodycote Technitrol Inc received?

Bodycote Technitrol 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 Bodycote Technitrol Inc come from?

All FDA import refusal data for Bodycote Technitrol 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.