Petra Hygienic Systems Int Ltd
⚠️ Moderate Risk
FEI: 3002869527 • Concord, Ontario • CANADA
FEI Number
3002869527
Location
Concord, Ontario
Country
CANADAAddress
90 Moyal Crt, , Concord, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/18/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 5/26/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/10/2015 | 64AAL20TRICLOSAN (DISINFECTANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/18/2003 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Petra Hygienic Systems Int Ltd's FDA import refusal history?
Petra Hygienic Systems Int Ltd (FEI: 3002869527) has 27 FDA import refusal record(s) in our database, spanning from 8/18/2003 to 6/18/2020.
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. Petra Hygienic Systems Int Ltd's FEI number is 3002869527.
What types of violations has Petra Hygienic Systems Int Ltd received?
Petra Hygienic Systems Int Ltd has been cited for 3 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 Petra Hygienic Systems Int Ltd come from?
All FDA import refusal data for Petra Hygienic Systems Int 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.