FDA 483 - SHE IS ORGANIC LLC - October 29, 2019

An FDA inspection of OHB IS ORGANIC LLC in Laguna Niguel, CA, revealed significant deficiencies in their quality system. The firm failed to establish procedures for corrective and preventive actions (CAPA) and for medical device reporting (MDR). These issues were noted while the firm has been importing and distributing She cotton tampons since late 2016.