FDA 483 - Coloplast Corp - April 11, 2024

Coloplast Manufacturing US, LLC in North Mankato, MN, a manufacturer of OTC drugs, was cited for three significant deficiencies during an FDA inspection. Observations included a lack of temperature mapping studies for drug product storage, absence of microbiological testing for Burkholderia Cepacia Complex in water used for non-sterile products, and inadequate written procedures for the site's Quality Unit responsibilities. These issues indicate potential risks to drug product quality and purity.