Company
JapanRohto Pharmaceutical Co., Ltd. (Ueno Plant), Iga, Japan – FDA Inspections
Inspection records and compliance data for Rohto Pharmaceutical Co., Ltd. (Ueno Plant) in Iga. 4 FDA inspections on record, 2 Form 483s, last inspected March 08, 2023.
Company Profile
This profile covers Rohto Pharmaceutical Co., Ltd. (Ueno Plant) based in Iga, Japan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected November 20, 2012. Last inspected March 8, 2023.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Cleaning / Sanitizing / Maintenance1 inspection
- Correct labels during finishing operations1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 8, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1202841 |
| March 2, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1046964 |
| November 14, 2014 | VAI | Human Drugs · Drug Quality Assurance | 906095 |
| November 20, 2012 | VAI | Human Drugs · Drug Quality Assurance | 812116 |
FDA documents
Form 483s (1)
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Company Information
Name
Rohto Pharmaceutical Co., Ltd. (Ueno Plant)
FEI Number
3003722237
Address
7 Chome 3 Ueno Technocenter, Yumegaoka, Iga, Japan
Country
Japan
ID: 43466404-a070-48c2-b431-c1009113e523