FDA 483 - Access Business Group LLC - June 05, 2026
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An FDA inspection of Access Business Group LLC in Ada, MI, revealed two significant observations related to manufacturing practices. The firm failed to maintain equipment and utensils to prevent contamination, with issues like active leaks, pooling water, and improperly stored hoses observed in manufacturing areas. Additionally, the laboratory lacked second-person verification for microbial plate reading, raising concerns about the accuracy of environmental monitoring and product release data.
ID · 157f1213-6705-469a-8f06-14f8ed324e2e