FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Spanish Drugmaker Cited for API Violations

Aug. 16, 2019
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A drug manufacturer in Málaga, Spain was cited for failing to test active pharmaceutical ingredients from China and other serious GMP violations.

A June 27 inspection of Farma Química Sur by the Spanish Agency of Medicines and Medical Devices revealed 31 deficiencies, including three “critical” and 20 “major” deficiencies, according to the agency’s filing in the EU’s EudraGMDP inspection database.

In one critical violation, the company received two API batches for the anti-parasite medication Ivermectin from Chinese drugmaker Zhejian Hisun Pharmaceutical. The supplier’s facility received a GMP non-compliance certificate in June 2016, but the active substance was considered critical so it could be imported provided each batch was tested. Farma Química, however, failed to carry out the required tests.

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