Pax-All Manufacturing Inc
⚠️ Moderate Risk
FEI: 3003986222 • Lasalle, Ontario • CANADA
FEI Number
3003986222
Location
Lasalle, Ontario
Country
CANADAAddress
5000 Howard Business Pky, , Lasalle, 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
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/17/2012 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/17/2012 | 60LAJ99ANALGESIC, N.E.C. | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/29/2012 | 60LAJ99ANALGESIC, N.E.C. | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 3/29/2012 | 60LAJ99ANALGESIC, N.E.C. | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 3/29/2012 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 3/29/2007 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/29/2007 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/29/2007 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/29/2007 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/29/2007 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/29/2007 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/29/2007 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/29/2007 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 10/18/2006 | 60LAJ99ANALGESIC, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pax-All Manufacturing Inc's FDA import refusal history?
Pax-All Manufacturing Inc (FEI: 3003986222) has 14 FDA import refusal record(s) in our database, spanning from 10/18/2006 to 4/17/2012.
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. Pax-All Manufacturing Inc's FEI number is 3003986222.
What types of violations has Pax-All Manufacturing Inc received?
Pax-All Manufacturing Inc 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 Pax-All Manufacturing Inc come from?
All FDA import refusal data for Pax-All Manufacturing 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.