FDA Inspection
X-Ray Systems, Inc.X-Ray Systems, Inc. – FDA Inspection, Sep 18, 2019
Record Details
This FDA Inspection record concerns X-Ray Systems, Inc., with an inspection on September 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ce15ee41-dc0a-4375-8e82-3ed20ab88ea7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102620
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.30(j)Design history file
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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 |
| March 4, 2022 | 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 1163948 - 2022-03-04
- FDA Inspection 1015986 - 2017-06-23
- FDA Inspection 663009 - 2010-05-21
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