483
Summit Orthodontic Services IncFDA 483 - Summit Orthodontic Services Inc - November 06, 2019
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Record Details
Summit Orthodontic Services Inc, a medical device labeler/relabeler in Munroe Falls, OH, received a Form FDA-483 citing significant quality system deficiencies. The inspection revealed a lack of documented procedures and records for supplier evaluation, control, and approval. Additionally, the firm failed to establish adequate document control procedures.
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ID · 9d60c336-c153-4dd0-a43e-bcb1003e0202