FDA Inspection
Philips Medical Systems (Cleveland) IncPhilips Medical Systems (Cleveland) Inc – FDA Inspection, Dec 3, 2010
Record Details
This FDA Inspection record concerns Philips Medical Systems (Cleveland) Inc, with an inspection on December 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 3, 2010
- Product Type
- Devices
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ID · 865edc4d-cdab-4c9c-8f01-e3842f4c5257
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 679230
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
17- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 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 806.10(b)Time to report - 10 days
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
Showing 10 of 17 citations.
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Other FDA inspections of Philips Medical Systems (Cleveland) Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| November 26, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 4, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 24, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 18, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Philips Medical Systems (Cleveland) Inc
- FDA Inspection 1260011 - 2025-01-16
- FDA Inspection 1111084 - 2019-11-26
- FDA Inspection 1091789 - 2019-06-04
- FDA Inspection 1072883 - 2018-10-24
- FDA Inspection 1022578 - 2017-08-18
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