Date:
Mon, 22 Jun 2026 09:23:13 EDT
Content:
The U.S. Food and Drug Administration (FDA) has published an untitled letter issued to Mixlab WI LLC, a producer based in Milwaukee, Wisconsin. The notice identifies specific regulatory concerns following an agency evaluation.
Issued on May 1, 2026, the letter was recently added to the OII FOIA Electronic Reading Room. Untitled letters are formal communications used by the FDA to cite violations that do not reach the threshold of a Warning Letter but still require the firm’s attention to maintain compliance with federal safety and quality standards.
The record, associated with FEI Number 3005946041, highlights the agency’s ongoing oversight of establishment types involved in production. Companies receiving such letters are expected to address the noted issues to ensure continued alignment with FDA regulations.
Source: FDA.gov
Link:
http://www.fda.gov/about-fda/fda-commissioner/mixlab-wi-llc-milwaukee-wi-untitled-letter-issued-05012026
Keywords:
FDA, Mixlab WI LLC, Untitled Letter, Milwaukee, Regulatory Compliance, FEI 3005946041