FDA WARNING_LETTER - McConnell Labs Inc. - October 18, 2022

This FDA Warning Letter, dated October 18, 2022, was issued to McConnell Labs Inc. following a review of records submitted in response to a July 30, 2021, request under section 704(a)(4) of the FD&C Act. The facility, registered as an OTC drug product manufacturer, including consumer antiseptic hand rubs, was found to have significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211), rendering its drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to verify identity of each component (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming raw materials (e.g., ethanol, isopropyl alcohol) for identity, relying solely on supplier Certificates of Analysis (COAs). No testing for methanol in incoming alcohol lots was performed, despite the supplier's COA stating the product was "not intended for use as an active ingredient in drug manufacturing." 2. **Failure to conduct final product testing (21 CFR 211.165(a)):** The firm did not perform adequate finished drug product testing, specifically lacking strength and identity testing of the active ingredient for hand sanitizers, instead only testing for weight, density