TAMPON INNOVATIONS LTD. – FDA 483, Jul 11, 2024

TAMPON INNOVATIONS, a manufacturer in Iliyantsi, Bulgaria, was inspected and cited for significant deficiencies in its complaint handling procedures. The firm failed to establish adequate processes for evaluating complaints for medical device reporting (MDR), including serious adverse events like toxic shock syndrome, and did not properly document complainant information. These issues indicate a lack of robust quality system controls for post-market surveillance.