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Horizon Tool Inc., a drug manufacturer in Greensboro, North Carolina, failed to comply with Current Good Manufacturing Practice (CGMP) regulations during a January 2025 FDA inspection of its facility. The company did not conduct required microbiological testing for batches of its AllShield E2 Sanitizing Hand Soap, an over-the-counter antibacterial product, and lacked established microbiological specifications for the product, leaving no scientific evidence that batches met appropriate safety standards before release to consumers. The firm acknowledged in its response that it had failed to complete product development activities and follow federal regulations, identifying this as the root cause of the violations.