FDA Inspection
Primus Sterilizer Co IncPrimus Sterilizer Co Inc – FDA Inspection, Mar 22, 2018
Record Details
This FDA Inspection record concerns Primus Sterilizer Co Inc, with an inspection on March 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 4cf2b354-ac85-461d-9a5e-01295fa2d8b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045252
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.25(b)Training records
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Primus Sterilizer Co Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 28, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 5, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Primus Sterilizer Co Inc
- FDA Inspection 1003248 - 2017-02-21
- FDA Inspection 914385 - 2015-01-28
- FDA Inspection 861769 - 2013-12-05
- FDA Inspection 834493 - 2013-05-10
- FDA Inspection 656794 - 2010-03-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.