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483
•PatCen Healthcare Inc.•January 14, 2020

FDA 483 - PatCen Healthcare Inc. - January 14, 2020

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Record Details

PatCen Healthcare Inc. in Bellevue, WA, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed deficiencies in the firm's medical device reporting procedures, specifically lacking timely transmission timelines. Additionally, the firm failed to ensure proper documentation of approval for quality system documents, as evidenced by missing signatures.

Company
PatCen Healthcare Inc.
Inspection Date
January 14, 2020
Product Type
Device
Office
Division of Human and Animal Food Operations - West VI
Person
  • Stephen R. Souza
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ID · 8f11b6d7-90aa-476d-a2b3-8329c8e846dd

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