FDA WARNING_LETTER - C.S.O. S.R.L. - September 04, 2013

During an FDA inspection of C.S.O. S.R.L. in Scandicci, Italy, from September 2-4, 2013, it was determined that the firm manufactures various ophthalmic devices, including Biomicroscope Slit Lamps and Surgical Microscopes. These products are classified as devices under the Federal Food, Drug, and Cosmetic Act.

The inspection revealed that the firm's devices are misbranded under section 502(t)(2) of the Act because the firm failed to furnish material or information required by section 519 of the Act and 21 CFR Part 803 - Medical Device Reporting (MDR). A significant violation identified was the failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. Specifically, the firm lacked a procedure for reporting medical device adverse events to the U.S. for products distributed there.

The FDA requires C.S.O. S.R.L. to notify the office in writing within fifteen business days of receiving the letter, detailing specific steps taken to correct the violations and prevent recurrence. This includes documentation of corrections and a timetable for implementation if actions will occur over time. A retroactive review of complaints may be necessary to ensure all required MDR reports are submitted. A follow-up inspection may be conducted to assure the adequacy of corrective actions. U.S. federal agencies may be