FDA Inspection
Thai Hospital Products Co., Ltd.Thai Hospital Products Co., Ltd. – FDA Inspection, Jun 22, 2023
Record Details
This FDA Inspection record concerns Thai Hospital Products Co., Ltd., with an inspection on June 22, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 960bcb15-33f6-44e8-a27b-1ea995eef3db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1209398
- 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 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Thai Hospital Products Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Thai Hospital Products Co., Ltd.
- FDA Inspection 1013186 - 2017-01-26
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