FDA 483 - Surgitech Inc - August 10, 2023

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.