483
SurgiMark, Inc.FDA 483 - SurgiMark, Inc. - August 08, 2017
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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.
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ID · 19ff51f2-d68e-4f4a-9b03-7a43c339549d