FDA Inspection
Bostal Drug Delivery Co., Ltd.FDA Inspection 1217731 - Bostal Drug Delivery Co., Ltd. - August 25, 2023
Record Details
This FDA Inspection record concerns Bostal Drug Delivery Co., Ltd., with an inspection on August 25, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- August 25, 2023
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ID · c186dfbd-0b4d-4fbc-aa6c-c7601946cc6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217731
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Bostal Drug Delivery Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | Not classified | Office of Inspections and Investigations |
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