FDA WARNING_LETTER - Silfradent Srl - August 01, 2019

An FDA inspection of the firm in Santa Sofia, Italy, from July 29 to August 1, 2019, revealed that the SURGYBONE SB 300NA device is adulterated under section 501(h) of the Act, as its manufacturing methods and controls do not conform with the Quality System regulation (21 CFR Part 820). The device is also misbranded under section 502(t)(2) for failing to provide information required by 21 CFR Part 803 (Medical Device Reporting). Key violations include the failure to establish and maintain design control procedures (21 CFR 820.30(a)), with the Design History File lacking critical elements like design inputs and validations. The firm also failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)), specifically regarding investigations into device failures and MDR reportability. Furthermore, the firm lacked written Medical Device Reporting (MDR) procedures as required by 21 CFR 803.17. The firm's responses to the design control and complaint handling violations were deemed inadequate, and the adequacy of the MDR response could not be determined. The firm is required to notify the FDA within fifteen business days of specific corrective actions, including documentation and a timetable for systemic changes. Failure to correct these violations may impact federal contracts and premarket approval applications for Class III devices.