GMP Compliance Inspection Outcome ReportPMDA

Copy

Name of product

Applicant name

Date of MA application or Date of MA

GMPCompliance Inspection Application date2018/02/28

Inspected site name

Address of the site inspected

Name of the manufacturer

Address

Accreditation category Pharmaceutical Affairs Law Article 36-1-4

Site Accreditation number and date2016/4/7

Outcome of the inspection In accordance with the Pharmaveutical act 14-6, we judged the facility as compliant

Remarks

System acceptance #

API: Acetaminophen MFGMP compliance Inspection

GMP Compliance Inspection conducted

We hereby inform of the outcome of the GMP Compliance Inspection

2018/06/18

PMDA

To Minister of Ministry of Health Labor and Walfare