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

Source: https://www.keypedia.com/records/483/apipharma-doo/397c28ab-5225-4b29-a7ed-c5774d7b4ee8

> FDA 483 for APIPHARMA  d.o.o on March 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APIPHARMA  d.o.o
- Inspection Date: 2025-03-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/apipharma-doo/c8c0530b-3406-4b3c-942e-3ed907c69d47

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8