FDA Inspection
Chugai Pharma Manufacturing Co. Ltd.Chugai Pharma Manufacturing Co. Ltd. – FDA Inspection, Sep 26, 2019
Record Details
This FDA Inspection record concerns Chugai Pharma Manufacturing Co. Ltd., with an inspection on September 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6e42bcb5-f01e-46d9-ae30-3880a7fc247c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1103317
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
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Other FDA inspections of Chugai Pharma Manufacturing Co. Ltd.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 30, 2018 | Not classified | Office of Inspections and Investigations | |
| November 10, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 1, 2017 | Not classified | Office of Inspections and Investigations | |
| March 24, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Chugai Pharma Manufacturing Co. Ltd.
- FDA Inspection 1236880 - 2024-04-02
- FDA Inspection 1091995 - 2018-10-30
- FDA Inspection 1031133 - 2017-11-10
- FDA Inspection 1028864 - 2017-09-01
- FDA Inspection 918526 - 2015-03-24
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