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FDA Inspection
•Philips Healthcare - VSS - Shanghai CDC•April 11, 2019

Philips Healthcare - VSS - Shanghai CDC – FDA Inspection, Apr 11, 2019

Record Details

This FDA Inspection record concerns Philips Healthcare - VSS - Shanghai CDC, with an inspection on April 11, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Philips Healthcare - VSS - Shanghai CDC
Inspection Date
April 11, 2019
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · 4f79d442-e8da-4643-9c3e-353ecd4f8747

Inspection Facts

Inspection number
1086440
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.22Quality audits - Lack of or inadequate procedures
  2. 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures

Full citation text and observation details available on the Dashboard.

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