FDA Inspection
OSTEOPORE INTERNATIONAL PTE LTDOSTEOPORE INTERNATIONAL PTE LTD – FDA Inspection, Sep 26, 2024
Record Details
This FDA Inspection record concerns OSTEOPORE INTERNATIONAL PTE LTD, with an inspection on September 26, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 26, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 64dd7d6c-742a-4dfc-a208-3115d028ff0f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1250099
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
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Other FDA inspections of OSTEOPORE INTERNATIONAL PTE LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for OSTEOPORE INTERNATIONAL PTE LTD
- FDA Inspection 1083988 - 2019-02-21
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