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FDA Inspection
•Philips Medical Systems Technologies Ltd•January 12, 2023

Philips Medical Systems Technologies Ltd – FDA Inspection, Jan 12, 2023

Record Details

This FDA Inspection record concerns Philips Medical Systems Technologies Ltd, with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company
Philips Medical Systems Technologies Ltd
Inspection Date
January 12, 2023
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Janet Pulver (FDA Associated Person)
View Company Profile

ID · a38a3b0e-9f85-4ff8-8118-6cdb31387a12

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1195326
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.100(a)Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Philips Medical Systems Technologies Ltd

1
DateClassificationOfficeProject area
September 5, 2019Not classifiedOffice of Inspections and Investigations
Other documents for Philips Medical Systems Technologies Ltd
  • FDA Inspection 1126550 - 2019-09-05

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