FDA 483 - Horizon Tool Inc. - January 16, 2025

HORIZON TOOL INC, an OTC manufacturer in Greensboro, NC, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to follow procedures for preventing objectionable microorganisms, lacked adequate control procedures for manufacturing processes, and did not test in-process materials or finished products for identity, strength, quality, and purity. Additionally, issues were noted with product labeling, lack of expiration dates, inadequate segregation of products, and a failure to conduct investigations into out-of-specification results.