FDA Inspection
Shionogi Pharma Co., Ltd.Shionogi Pharma Co., Ltd. – FDA Inspection, Jul 1, 2025
Record Details
This FDA Inspection record concerns Shionogi Pharma Co., Ltd., with an inspection on July 1, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · d6c61d37-7d00-48e6-ad33-c7705efb6abc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1275087
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
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Other FDA inspections of Shionogi Pharma Co., Ltd.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2019 | Not classified | Office of Inspections and Investigations | |
| September 28, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 1, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Shionogi Pharma Co., Ltd.
- FDA Inspection 1085190 - 2019-03-15
- FDA Inspection 1069417 - 2018-09-28
- FDA Inspection 1009607 - 2016-09-16
- FDA Inspection 1009606 - 2016-09-16
- FDA Inspection 874759 - 2014-04-01
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