483
Surgitech IncSurgitech Inc – FDA 483, Aug 10, 2023
Record Details
Surgitech Inc, a specification developer in Carlsbad, CA, was inspected by the FDA from August 8-10, 2023, and received a Form FDA 483 with ten observations. The inspection revealed significant deficiencies across its quality system, including repeat observations related to design control and device history records. The firm demonstrated a systemic lack of adherence to established procedures and regulatory requirements, indicating a severe state of non-compliance.
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ID · c99c135a-e6e0-4b6c-aeb3-61579fafa8bf
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