FDA Inspection
X-Ray Systems, Inc.X-Ray Systems, Inc. – FDA Inspection, Mar 4, 2022
Record Details
This FDA Inspection record concerns X-Ray Systems, Inc., with an inspection on March 4, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- X-Ray Systems, Inc.
- Inspection Date
- March 4, 2022
- Product Type
- Devices
View Company Profile
ID · bebe8517-9175-4725-b81c-ce0b7e5e2ba7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1163948
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of X-Ray Systems, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 23, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2010 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for X-Ray Systems, Inc.
- FDA Inspection 1334778 - 2026-09-03
- FDA Inspection 1102620 - 2019-09-18
- FDA Inspection 1015986 - 2017-06-23
- FDA Inspection 663009 - 2010-05-21
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.