Company
CanadaPetra Hygienic Systems Int Ltd, Concord, Canada – FDA Inspections
Inspection records and compliance data for Petra Hygienic Systems Int Ltd in Concord. 4 FDA inspections on record (2 OAI), 1 Form 483, 1 warning letter, last inspected April 22, 2022.
Company Profile
This profile covers Petra Hygienic Systems Int Ltd based in Concord, Canada.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected February 9, 2012. Last inspected April 22, 2022.
Most cited issue areas
- Identity Testing of Each Component3 inspections
- Procedures not in writing, fully followed2 inspections
- Testing and release for distribution2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 22, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1168565 |
| December 21, 2018 | OAI | Human Drugs · Drug Quality Assurance | 1075197 |
| December 12, 2014 | VAI | Human Drugs · Drug Quality Assurance | 911653 |
| February 9, 2012 | NAI | Foods & Cosmetics, Human Drugs · Colors and Cosmetics Technology | 770125 |
FDA documents
Form 483s (1)
Warning Letters (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Petra Hygienic Systems Int Ltd
FEI Number
3002869527
Address
90 Moyal Crt, Concord, Canada
Country
Canada
ID: 0413dd25-8e8f-4a44-8316-0ded90ea4aac