Midlab Incorporated Warning Letter Details

Summary

Midlab Incorporated's drug manufacturing facility in Athens, Tennessee was found in significant violation of Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in August 2022, with their drug products deemed adulterated. The company's "MAXIM Instant Foam Hand Sanitizer" was flagged as an unapproved new drug introduced into interstate commerce, while three other MAXIM antibacterial products were found to be misbranded under federal law. The FDA identified specific compliance failures including the firm's failure to conduct appropriate laboratory testing for each batch of drug product, among other violations, and determined that the company's response to the initial FDA 483 inspection findings was inadequate and lacked sufficient corrective action details.