Date:
July 1, 2026
Content:
The U.S. Food and Drug Administration (FDA) has issued a Form 483 to Mixlab WI LLC, a producer of non-sterile drug products located in Milwaukee, Wisconsin, following a recent inspection of their facility.
The Form 483 was issued on July 24, 2025, after FDA investigators concluded their site visit. This regulatory document is used to notify a company’s management of objectionable conditions observed during an inspection that may violate the Federal Food, Drug, and Cosmetic Act and related regulations.
As a producer of non-sterile drug products, Mixlab WI LLC is required to maintain specific manufacturing standards. The issuance of this form indicates that investigators identified areas where the facility’s processes or environment did not meet agency expectations for quality control and safety during the time of the audit.
Typically, firms receiving a Form 483 are encouraged to submit a written response to the FDA detailing their plan for corrective actions. This oversight is part of the agency’s ongoing commitment to ensuring that pharmaceutical products are manufactured under appropriate conditions for public use.
Source: FDA OII FOIA Electronic Reading Room
Link:
http://www.fda.gov/about-fda/fda-commissioner/mixlab-wi-llc-milwaukee-wi-483-issued-07242025
Keywords:
FDA Form 483, Mixlab WI LLC, Milwaukee, Non-sterile Drug Products, FDA Inspection