FDA 483 - BLIS Technologies Limited - April 04, 2025

BLIS Technologies Limited, a dietary supplement manufacturer, received two observations during an FDA inspection in Dunedin, New Zealand. The firm failed to verify that finished batches of dietary supplements meet product specifications and lacked established acceptance criteria for strength specifications for certain ingredients. Additionally, the company did not provide the FDA with information on the scheduled process for a new acidified food product before packing it.