483
Sac, LlcFDA 483 - Sac, Llc - August 27, 2024
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Record Details
Sac, Llc, a medical device manufacturer in Sanford, FL, was inspected by the FDA from August 21-27, 2024. The inspection revealed significant deficiencies across multiple quality system areas, including complaint handling, corrective and preventive actions, nonconforming product control, document control, incoming product acceptance, and training. These observations indicate a systemic lack of adequately established and followed procedures.
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ID · 1344ae42-c800-4bec-ac23-6ed9593e740a