FDA Inspection
Philips Medical Systems DMC GmbHPhilips Medical Systems DMC GmbH – FDA Inspection, Jan 19, 2023
Record Details
This FDA Inspection record concerns Philips Medical Systems DMC GmbH, with an inspection on January 19, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 87215a9b-73e8-4ab2-95be-6f4a5f11951c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195414
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Philips Medical Systems DMC GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2015 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 14, 2013 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Philips Medical Systems DMC GmbH
- FDA Inspection 933942 - 2015-07-09
- FDA Inspection 843790 - 2013-06-14
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