Rite-Kem Incorporated Warning Letter Details

Summary

Rite-Kem Incorporated, a drug manufacturer of OTC products including hand sanitizers, antimicrobial hand soap, and antimicrobial towels, violated Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in September 2024. The company failed to perform adequate laboratory testing of finished drug product batches for identity and strength of active ingredients (such as benzalkonium chloride and chloroxylenol) prior to release, instead only testing pH, viscosity, color, appearance, and odor, and did not conduct required microbiological testing. The company's proposed remediation timeline of approximately 9 months was deemed inadequate by FDA, as the response addressed only ethanol and did not sufficiently address the full scope of testing deficiencies.