483
KENERIC HEALTHCAREFDA 483 - KENERIC HEALTHCARE - June 26, 2025
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An FDA inspection of Keneric Healthcare LLC, a medical device manufacturer in Allen, TX, from June 24-26, 2025, identified one significant observation. The firm's internal audit procedure was found to be deficient, as individuals with direct responsibility for audited activities were conducting the audits, compromising independence. This indicates a weakness in the firm's quality system oversight.
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