483
Could YouFDA 483 - Could You - July 11, 2024
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Record Details
An FDA inspection of Could You, a medical device manufacturer in Oceanside, CA, revealed deficiencies in their quality audit procedures. Specifically, the firm failed to adequately establish procedures for quality audits and did not maintain internal audit records as required by their own SOP. This indicates a moderate severity issue related to quality system compliance.
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ID · 339112e8-46d4-4414-825b-be172c2fd05f