FDA Inspection
BIOPTIMAL INTERNATIONAL PTE. LTD.BIOPTIMAL INTERNATIONAL PTE. LTD. – FDA Inspection, Nov 9, 2023
Record Details
This FDA Inspection record concerns BIOPTIMAL INTERNATIONAL PTE. LTD., with an inspection on November 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7cdc8e41-1440-424d-9af4-3539b2994d44
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1222563
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 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
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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