FDA WARNING_LETTER - Sanit Technologies, LLC dba Durisan - March 05, 2021

The FDA inspected Sanit Technologies LLC., dba Durisan, a drug manufacturing facility, from March 1 to 5, 2021, and found significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211). Consequently, the firm's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act. Key deficiencies included the quality control unit's failure to ensure drug products met CGMP and established specifications, leading to the release of Durisan Hand Sanitizer, Alcohol-Free, that failed microbial count specifications. Specifically, products were released with high levels of bacteria and yeast/molds, including Burkholderia cepacia, an opportunistic pathogen. The quality unit also failed to uphold commitments made during a prior regulatory meeting regarding water system monitoring, knowingly releasing contaminated water for manufacturing. Furthermore, there was a lack of adequate procedures and oversight for finished product specifications and the stability program. The firm acknowledged ceasing all drug product manufacturing and distribution from the site as of June 30, 2021. Remediation of these CGMP violations is required if operations resume. The FDA demands a written response within 15 working days detailing corrective actions and prevention measures, warning of potential legal action, contract withholding, and export certificate denial if violations remain unaddressed.