483
PatCen Healthcare Inc.PatCen Healthcare Inc. – FDA 483, Jan 14, 2020
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.
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ID · 8f11b6d7-90aa-476d-a2b3-8329c8e846dd
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