FDA Inspection
Brymill CorporationBrymill Corporation – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Brymill Corporation, with an inspection on February 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e75c7fc6-20db-4d85-b50a-04e9e54a3047
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1042003
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Brymill Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 12, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 7, 2008 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Brymill Corporation
- FDA Inspection 838562 - 2013-06-25
- FDA Inspection 639664 - 2010-01-12
- FDA Inspection 546390 - 2008-11-07
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.