FDA 483 - APIPHARMA d.o.o - March 28, 2025

APIPHARMA d.o.o, an OTC manufacturer in Nasice, Croatia, was cited for numerous significant deficiencies across its quality, laboratory, and production systems during an FDA inspection. Key issues include a lack of original raw data and calculations for product release, inadequate stability testing and storage conditions, and failures in establishing appropriate testing specifications and procedures. The report also highlights concerns with electronic record trustworthiness, forged signatures, and insufficient complaint investigations, indicating a broad breakdown in GMP compliance.