Micrylium Laboratories
⚠️ Moderate Risk
FEI: 3010219104 • North York, Ontario • CANADA
FEI Number
3010219104
Location
North York, Ontario
Country
CANADAAddress
5000m Dufferin St, , North York, Ontario, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2013 | 62FAJ08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 10/30/2013 | 62FAJ08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 8/13/2013 | 61HDL99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) | |
| 4/17/2013 | 62HBL99ANTI-MICROBIAL N.E.C. | Detroit District Office (DET-DO) | |
| 4/17/2013 | 62HBL99ANTI-MICROBIAL N.E.C. | Detroit District Office (DET-DO) | |
| 4/17/2013 | 62HBL99ANTI-MICROBIAL N.E.C. | Detroit District Office (DET-DO) | |
| 4/17/2013 | 62HBL99ANTI-MICROBIAL N.E.C. | Detroit District Office (DET-DO) | |
| 4/17/2013 | 62HBL99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/17/2013 | 62HBL99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/17/2013 | 62HBL99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/17/2013 | 62HBL99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 10/14/2011 | 62HBL99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Micrylium Laboratories's FDA import refusal history?
Micrylium Laboratories (FEI: 3010219104) has 12 FDA import refusal record(s) in our database, spanning from 10/14/2011 to 10/30/2013.
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. Micrylium Laboratories's FEI number is 3010219104.
What types of violations has Micrylium Laboratories received?
Micrylium Laboratories has been cited for 5 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 Micrylium Laboratories come from?
All FDA import refusal data for Micrylium Laboratories 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.