FDA Inspection
Pressure Tech, Inc.Pressure Tech, Inc. – FDA Inspection, Apr 2, 2009
Record Details
This FDA Inspection record concerns Pressure Tech, Inc., with an inspection on April 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pressure Tech, Inc.
- Inspection Date
- April 2, 2009
- Product Type
- Devices
View Company Profile
ID · 27ccc0f2-7495-4d94-b84c-f78284737ad0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 573593
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.181(c)DMR QA procedures and specifications
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pressure Tech, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pressure Tech, Inc.
- FDA Inspection 888628 - 2014-07-17
- FDA Inspection 786258 - 2012-06-14
- FDA Inspection 659854 - 2010-04-22
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.