PLZ Corp.
⚠️ Moderate Risk
FEI: 3001956890 • Mississauga, Ontario • CANADA
FEI Number
3001956890
Location
Mississauga, Ontario
Country
CANADAAddress
6080 Vipond Dr, , Mississauga, 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.
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2021 | 62HAC05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 6/1/2012 | 63JAL17ZINC ACETATE (CHELATING AGENT) | New York District Office (NYK-DO) | |
| 6/1/2012 | 63JBL17ZINC ACETATE (CHELATING AGENT) | New York District Office (NYK-DO) | |
| 9/24/2010 | 62FBQ99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/24/2007 | 53FA05HAIR COLOR SPRAYS (HAIR COLORING PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/26/2006 | 66VAQ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 1/26/2006 | 62FAQ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) | |
| 4/18/2005 | 53BA99OTHER BATH PREPARATIONS, N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
Frequently Asked Questions
What is PLZ Corp.'s FDA import refusal history?
PLZ Corp. (FEI: 3001956890) has 8 FDA import refusal record(s) in our database, spanning from 4/18/2005 to 8/19/2021.
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. PLZ Corp.'s FEI number is 3001956890.
What types of violations has PLZ Corp. received?
PLZ Corp. 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 PLZ Corp. come from?
All FDA import refusal data for PLZ Corp. 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.