PMDA inspection

SK Biotek Ireland Limited

PMDA inspection 5130608045234 · Ireland · Suitable

Key facts

Control number 5130608045234
Manufacturing site SK Biotek Ireland Limited
Location Watery Lane, Swords, Country Dublin, Ireland
Country Ireland
Product type Pharmaceuticals
Application type Complete Change
Inspection method Remote
Inspection month Nov 1, 2025
Result Suitable
Result notified Nov 20, 2025
PMDA registration AG20600093

About PMDA GMP inspections (Japan)

Japan's PMDA conducts GMP and QMS inspections of domestic and foreign manufacturing sites that supply the Japanese market.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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