FDA 483 - Qingdao Kunhao Biotech Co.,Ltd - January 14, 2025

During an inspection conducted by the U.S. Food and Drug Administration from January 13-14, 2025, Qingdao Kunhao Biotech Co., Ltd. received an FDA Form 483 detailing significant observations of objectionable conditions. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, identified two primary areas of concern impacting food safety.

Firstly, the firm was cited for failing to clean utensils and equipment in a manner that protects against contamination. Specifically, direct food contact surfaces used for Ready-To-Eat (RTE) dried mealworms were observed with caked insect processing debris, despite the equipment reportedly being cleaned and sanitized. This poses a direct risk of product contamination.

Secondly, the FDA found that Qingdao Kunhao Biotech Co., Ltd. did not implement effective measures to exclude pests or protect animal food from contamination. Inspectors observed apparent rodent excreta pellets and mammalian feces in close proximity to stored mealworm raw material. Furthermore, structural deficiencies such as gaps along a raw material entry door and an unscreened hole leading from the outside directly into the processing workshop presented potential pest entry points.

These observations indicate that products may have been prepared, packed, or held under insanitary conditions, potentially rendering them injurious to health. While these are initial observations and not a final determination, the company is required to discuss objections or submit corrective actions to the FDA, demonstrating how they will address these critical sanitation and pest control issues to ensure compliance.