PMDA inspection

Shire Human Genetic Therapies, Inc. (300 SW)

PMDA inspection 5130708006769 · USA · Suitable

Key facts

Control number 5130708006769
Manufacturing site Shire Human Genetic Therapies, Inc. (300 SW)
Location 300 Shire Way, Lexington, MA 02421, USA
Country USA
Product type Pharmaceuticals
Application type New
Inspection method Remote
Inspection month Jul 1, 2025
Result Suitable
Result notified Jul 30, 2025

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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