FDA Inspection
Pacific Hospital Supply Co., LtdPacific Hospital Supply Co., Ltd – FDA Inspection, Feb 22, 2017
Record Details
This FDA Inspection record concerns Pacific Hospital Supply Co., Ltd, with an inspection on February 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3471bf83-2497-43c0-a701-e3b8d0569006
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1004162
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Pacific Hospital Supply Co., Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2023 | Not classified | Office of Inspections and Investigations | |
| August 29, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pacific Hospital Supply Co., Ltd
- FDA Inspection 1208815 - 2023-05-12
- FDA Inspection 848688 - 2013-08-29
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