FDA Inspection
Comfort Acrylics, Inc.Comfort Acrylics, Inc. – FDA Inspection, Apr 19, 2019
Record Details
This FDA Inspection record concerns Comfort Acrylics, Inc., with an inspection on April 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e8c3b930-dbb6-4ee4-8229-cff8ffa6820d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087016
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.40Procedures not adequately established or maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Comfort Acrylics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 7, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 8, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Comfort Acrylics, Inc.
- FDA Inspection 909014 - 2015-01-07
- FDA Inspection 813178 - 2013-01-08
- FDA Inspection 727423 - 2011-03-18
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.