PMDA inspection

KBI Biopharma, Inc. (Durham)

PMDA inspection 5130608017234 · USA · Suitable

Key facts

Control number 5130608017234
Manufacturing site KBI Biopharma, Inc. (Durham)
Location 1101 Hamlin Rd., Durham, North Carolina (NC) 27704, United States (USA)
Country USA
Product type Pharmaceuticals
Application type New
Inspection method On-Site
Inspection month Sep 1, 2024
Result Suitable
Result notified Nov 26, 2024
PMDA registration AG30400625

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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