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Tokuhon Corporation Miyashiro Factory, Minamisaitama-Gun, Japan – FDA Inspections

Inspection records and compliance data for Tokuhon Corporation Miyashiro Factory in Minamisaitama-Gun. 2 FDA inspections on record, 1 Form 483, last inspected November 04, 2016.

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Company Profile

This profile covers Tokuhon Corporation Miyashiro Factory based in Minamisaitama-Gun, Japan.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
2
NAI
0
Form 483s
1
Warning letters
0

First inspected September 23, 2011. Last inspected November 4, 2016.

Most cited issue areas

  • Control procedures to monitor and validate performance2 inspections
  • Changes to Procedures Not Reviewed, Approved1 inspection
  • Expiration date lacking1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
November 4, 2016VAIHuman Drugs · Drug Quality Assurance995997
September 23, 2011VAIHuman Drugs · Drug Quality Assurance749511
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Kohei Shitara, M.D.
Naoki Atsuta
Nippon Aerosil Co., Ltd.
Hirotaka Nagashima
Shiseido Co., Ltd.
Sumitomo Chemical Co., Ltd.
Company Information

Name

Tokuhon Corporation Miyashiro Factory

FEI Number

1000310275

Address

1010, Azayamazaki; Miyashiro-Machi, Minamisaitama-Gun, Japan

Country

Japan

ID: 59dd37b2-71ac-4be9-bfb9-6ca3b0260f13

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