FDA WARNING_LETTER - MAKRA KOZMETIKA D.O.O. - April 12, 2024

The FDA inspected Makra Kozmetika D.O.O. (FEI 3019638306) in Kranj, Slovenia, from April 8-12, 2024, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm failed to conduct appropriate laboratory testing for finished OTC drug products, including identity, strength, and microbiological specifications, prior to release, and used cosmetic standards for microbiological testing instead of USP protocols. They also failed to test incoming raw materials and APIs for identity, purity, and strength, and did not validate supplier test analyses.

Furthermore, the firm lacked adequate written procedures for production and process control, including process validation, and failed to validate and monitor their water system for drug manufacturing. Cleaning validation for equipment was also absent. The firm failed to establish an adequate Quality Unit (QU) with written procedures for critical quality management system elements like change control, complaints, and investigations.

The FDA deemed the firm's April 29, 2024, response inadequate, citing a lack of comprehensive retrospective review, insufficient detail on corrective actions, and absence of risk assessments for products already on the market. Required corrective actions include comprehensive independent assessments of laboratory practices, material systems, and the QU, detailed remediation plans, timelines for full testing of reserve samples, and validation of processes, water systems, and cleaning procedures. The FDA placed the firm on Import Alert 6