SurgiMark, Inc.August 8, 2017

FDA 483 - SurgiMark, Inc. - August 08, 2017

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Record Details

An FDA inspection of SurgiMark, Inc. in Yakima, WA, conducted on August 7-8, 2017, identified two significant quality system deficiencies. The firm failed to establish adequate procedures for receiving and evaluating complaints, specifically regarding Medical Device Report (MDR) reportability. Additionally, the inspection found that the firm's sampling plans for product inspection were not based on valid statistical rationale.

Company: SurgiMark, Inc.
Inspection Date: August 8, 2017
Product Type: Device
Office: Division of Human and Animal Food Operations - West VI
Person: Stephen R. Souza

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