Makra Kozmetika D.O.O. Warning Letter Details

Summary

Makra Kozmetika D.O.O., a drug manufacturing facility in Slovenia, was cited for significant Current Good Manufacturing Practice (CGMP) violations during an April 2024 FDA inspection. The company failed to conduct required quality control testing on over-the-counter drug products, including identity, strength, and microbiological testing, before releasing them to the U.S. market, leaving no assurance that finished products met established specifications. These deficiencies meant the firm's drug products were considered adulterated under the Federal Food, Drug, and Cosmetic Act. The company had begun implementing corrective measures through a quality management system in response to the FDA's observations.